`RESEARCH
`
`
`APPLICATION NUMBER:
`
`211192Orig1s000
`
`PROPRIETARY NAME REVIEW(S)
`
`
`
`
`
`
`
`PROPRIETARY NAME REVIEW
`Division of Medication Error Prevention and Analysis (DMEPA)
`Office of Medication Error Prevention and Risk Management (OMEPRM)
`Office of Surveillance and Epidemiology (OSE)
`Center for Drug Evaluation and Research (CDER)
`
`*** This document contains proprietary information that cannot be released to the
`public***
`
`Date of This Review:
`March 21, 2018
`Application Type and Number: NDA 211192
`Product Name and Strength:
`Tibsovo (ivosidenib) tablet, 250 mg
`Product Type:
`Single Ingredient
`Rx or OTC:
`Rx
`Applicant/Sponsor Name:
`Agios Pharmaceuticals, Inc.
`Panorama #:
`2017-19922977
`DMEPA Safety Evaluator:
`Susan Rimmel, PharmD
`DMEPA Team Leader:
`Hina Mehta, PharmD
`
`Reference ID: 4237570
`
`
`
`1
`
`Contents
`INTRODUCTION........................................................................................................1
`1.1
`Regulatory History................................................................................................1
`1.2
`Product Information ..............................................................................................1
`2 RESULTS.....................................................................................................................1
`2.1 Misbranding Assessment ......................................................................................2
`2.2
`Safety Assessment.................................................................................................2
`3 CONCLUSIONS..........................................................................................................3
`3.1
`Comments to the Applicant...................................................................................3
`4 REFERENCES.............................................................................................................4
`APPENDICES .....................................................................................................................5
`
`
`
`Reference ID: 4237570
`
`
`
`INTRODUCTION
`1
`This review evaluates the proposed proprietary name, Tibsovo, from a safety and misbranding
`perspective. The sources and methods used to evaluate the proposed name are outlined in the
`reference section and Appendix A respectively. The Applicant submitted an external name
`study, conducted by
` for this proposed proprietary name (reviewed
`previously in OSE Review # 2016-10972788).
`
`REGULATORY HISTORY
`1.1
`The Applicant previously submitted the proposed proprietary name, Tibsovo, under IND 119341
`on October 25, 2016. We found the proposed proprietary name, Tibsovo, acceptable in OSE
`Review # 2016-10972788 on February 1, 2017.a
`Thus, the Applicant submitted the name, Tibsovo, for review under NDA 211192 on December
`22, 2017.
`
`PRODUCT INFORMATION
`1.2
`The following product information is provided in the proprietary name submission received on
`December 22, 2017, and draft labeling submission received on December 21, 2017.
`Intended Pronunciation: tib-SOH-voh
`
` Active Ingredient: ivosidenib
`Indication of Use: for the treatment of patients with relapsed or refractory (R/R) acute
`
`myelogenous leukemia (AML) harboring an isocitrate dehydrogenase-1 (IDH1) mutation
` Route of Administration: oral
` Dosage Form: tablet
` Strength: 250 mg
` Dose and Frequency: 500 mg (2 tablets) once daily
` How Supplied: 60 count bottles
` Storage: 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F
`to 86°F)
`
`2 RESULTS
`The following sections provide information obtained and considered in the overall evaluation of
`the proposed proprietary name.
`
`a Rimmel, S. Proprietary Name Review for Tibsovo. Silver Spring (MD): FDA, CDER, OSE, DMEPA (US); 2017
`FEB 01. Panorama No. 2016-10972788.
`
`Reference ID: 4237570
`
`1
`
`(b) (4)
`
`
`
`2.1 MISBRANDING ASSESSMENT
`
`The Office of Prescription Drug Promotion (OPDP) determined that the proposed name would
`not misber the proposed product. The Division of Medication Error Prevention and Analysis
`(DMEPA) and the Division of Hematology Products (DHP) concurred with the findings of
`OPDP’S assessment of the proposed name.
`
`2.2
`
`SAFETY ASSESSMENT
`
`The following aspects were considered in the safety evaluation of the name.
`
`2.2.1 United States Adopted Names (USAN) Search
`
`There is no USAN stem present in the proprietary name.b
`
`2.2.2 Components ofthe Proposed Proprietary Name
`
`The Applicant did not provide a derivation or intended meaning for the proposed name, Tibsovo,
`in their submission. This proprietary name is comprised of a single word that does not contain
`any components (i.e., a modifier, route of administration, dosage form, etc.) that are misleading
`or can contribute to medication error.
`
`2.2.3 Comments from Other Review Disciplines at Initial Review
`
`In response to the OSE January 11, 2018, e-mail, DHP did not forward any comments or
`concerns relating to the proposed proprietary name at the initial phase of the review.
`
`2.2.4 FDA Name Simulation Studies
`
`Eighty-five (n = 85) practitioners participated in DMEPA’S prescription studies (Appendix B).
`One participant in the voice study transcribed Tibsovo as “Tesovo,” which is
`M0
`WW);
`an“: aND
`Despite this close hit in the FDA name simulation study, we find that the name pair, Tibsovo and
`“0*“, have minimal potential of confusion for the following reasons:
`
`(M)
`
`We evaluate this name pair in Appendix E.
`
`2.2.5 Phonetic and Orthographic Computer Analysis (POCA) Search Results
`
`Our POCA searchd identified 34 names with the combined score of 255% or individual
`
`orthographic or phonetic score of 270%. We had identified and evaluated some of the names in
`
`" USAN stem search conducted on February 27. 2018.
`
`(5) (4)
`
`“ POCA search conducted on February 27. 2018. in version 4.2.
`
`Reference ID: 4237570
`
`
`
`our previous proprietary name review. We re-evaluated the previously identified names of
`concern considering any lessons learned from recent post-marketing experience, which may have
`altered our previous conclusion regarding the acceptability of the name. We note that none of
`the product characteristics have changed and we agree with the findings from our previous
`review for the names evaluated previously. Therefore, we identified seven (n = 7) names not
`previously analyzed. These names are included in Table 1 below.
`
`2.2.6 Names Retrieved for Review Organized by Name Pair Similarity
`Table 1 lists the number of names retrieved from our POCA search. These name pairs are
`organized as highly similar, moderately similar, or low similarity for further evaluation.
`
`Table 1. Similarity Category
`
`Highly similar name pair:
`combined match percentage score ≥70%
`Moderately similar name pair:
`combined match percentage score ≥55% to ≤69%
`Low similarity name pair:
`combined match percentage score ≤54%
`
`Number of
`Names
`0
`
`5
`
`2
`
`2.2.7 Safety Analysis of Names with Potential Orthographic, Spelling, and Phonetic
`Similarities
`Our analysis of the seven names contained in Table 1 determined none of the names will pose a
`risk for confusion as described in Appendices C through H.
`
`2.2.8 Communication of DMEPA’s Analysis at Midpoint of Review
`DMEPA communicated our findings to DHP via e-mail on March 21, 2018. At that time, we
`also requested additional information or concerns that could inform our review. Per e-mail
`correspondence from DHP on March 21, 2018, they stated no additional concerns with the
`proposed proprietary name, Tibsovo.
`
`3 CONCLUSION
`The proposed proprietary name is acceptable.
`If you have any questions or need clarifications, please contact Neil Vora, OSE project manager,
`at 240-402-4845.
`
`COMMENTS TO THE APPLICANT
`3.1
`We have completed our review of the proposed proprietary name, Tibsovo, and have concluded
`that this name is acceptable.
`
`Reference ID: 4237570
`
`3
`
`
`
`If any of the proposed product characteristics, as stated in your submission received on
`December 22, 2017, are altered prior to approval of the marketing application, the name must be
`resubmitted for review.
`
`Reference ID: 4237570
`
`4
`
`
`
`4
`
`REFERENCES
`
`1. USAN Stems (http://www.ama-assn.org/ama/pub/physician-resources/medical-science/united-
`states-adopted-names-council/naming-guidelines/approved-stems.page)
`USAN Stems List contains all the recognized USAN stems.
`
`2. Phonetic and Orthographic Computer Analysis (POCA)
`POCA is a system that FDA designed. As part of the name similarity assessment, POCA is used to
`evaluate proposed names via a phonetic and orthographic algorithm. The proposed proprietary name is
`converted into its phonemic representation before it runs through the phonetic algorithm. Likewise, an
`orthographic algorithm exists that operates in a similar fashion. POCA is publicly accessible.
`Drugs@FDA
`Drugs@FDA is an FDA Web site that contains most of the drug products approved in the United States
`since 1939. The majority of labels, approval letters, reviews, and other information are available for drug
`products approved from 1998 to the present. Drugs@FDA contains official information about FDA-
`approved brand name and generic drugs; therapeutic biological products, prescription and over-the-
`counter human drugs; and discontinued drugs (see Drugs @ FDA Glossary of Terms, available at
`http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm#ther biological).
`
`RxNorm
`
`RxNorm contains the names of prescription and many OTC drugs available in the United States. RxNorm
`includes generic and branded:
`
` Clinical drugs – pharmaceutical products given to (or taken by) a patient with therapeutic or
`diagnostic intent
` Drug packs – packs that contain multiple drugs, or drugs designed to be administered in a
`specified sequence
`
`Radiopharmaceuticals, contrast media, food, dietary supplements, and medical devices, such as bandages
`and crutches, are all out of scope for RxNorm
`(http://www.nlm.nih.gov/research/umls/rxnorm/overview.html#).
`
`Division of Medication Errors Prevention and Analysis proprietary name consultation requests
`This is a list of proposed and pending names that is generated by the Division of Medication Error
`Prevention and Analysis from the Access database/tracking system.
`
`3. Electronic Drug Registration and Listing System (eDRLS) database
`The electronic Drug Registration and Listing System (eDRLS) was established to supports the FDA’s
`Center for Drug Evaluation and Research (CDER) goal to establish a common Structured Product
`Labeling (SPL) repository for all facilities that manufacture regulated drugs. The system is a reliable, up-
`to-date inventory of FDA-regulated, drugs and establishments that produce drugs and their associated
`information.
`
`Reference ID: 4237570
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`5
`
`
`
`APPENDICES
`Appendix A
`FDA’s Proprietary Name Risk Assessment evaluates proposed proprietary names for
`misbranding and safety concerns.
`1. Misbranding Assessment: For prescription drug products, OPDP assesses the name for
`misbranding concerns. For over-the-counter (OTC) drug products, the misbranding
`assessment of the proposed name is conducted by DNDP. OPDP or DNDP evaluates
`proposed proprietary names to determine if the name is false or misleading, such as by
`making misrepresentations with respect to safety or efficacy. For example, a fanciful
`proprietary name may misbrand a product by suggesting that it has some unique
`effectiveness or composition when it does not (21 CFR 201.10(c)(3)). OPDP or DNDP
`provides their opinion to DMEPA for consideration in the overall acceptability of the
`proposed proprietary name.
`2. Safety Assessment: The safety assessment is conducted by DMEPA, and includes the
`following:
`a. Preliminary Assessment: We consider inclusion of USAN stems or other characteristics
`that when incorporated into a proprietary name may cause or contribute to medication
`errors (i.e., dosing interval, dosage form/route of administration, medical or product name
`abbreviations, names that include or suggest the composition of the drug product, etc.)
`See prescreening checklist below in Table 2*. DMEPA defines a medication error as any
`preventable event that may cause or lead to inappropriate medication use or patient harm
`while the medication is in the control of the health care professional, patient, or
`consumer. e
`
`e National Coordinating Council for Medication Error Reporting and Prevention.
`http://www nccmerp.org/aboutMedErrors html. Last accessed 10/11/2007.
`
`Reference ID: 4237570
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`6
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`
`
`*Table 2- Prescreening Checklist for Proposed Proprietary Name
`
`Answer the questions in the checklist below. Affirmative answers
`to any of these questions indicate a potential area of concern that
`should be carefully evaluated as described in this guidance.
`Y/N Is the proposed name obviously similar in spelling and pronunciation to other
`names?
`Proprietary names should not be similar in spelling or pronunciation to proprietary
`names, established names, or ingredients of other products.
`Y/N Are there inert or inactive ingredients referenced in the proprietary name?
`Proprietary names should not incorporate any reference to an inert or inactive
`ingredient in a way that might create an impression that the ingredient’s value is
`greater than its true functional role in the formulation (21 CFR 201.10(c)(4)).
`Y/N Does the proprietary name include combinations of active ingredients?
`Proprietary names of fixed combination drug products should not include or
`suggest the name of one or more, but not all, of its active ingredients (see 21 CFR
`201.6(b)).
`Y/N Is there a United States Adopted Name (USAN) stem in the proprietary name?
`Proprietary names should not incorporate a USAN stem in the position that USAN
`designates for the stem.
`Y/N Is this proprietary name used for another product that does not share at least
`one common active ingredient?
`Drug products that do not contain at least one common active ingredient should not
`use the same (root) proprietary name.
`Y/N Is this a proprietary name of a discontinued product?
`Proprietary names should not use the proprietary name of a discontinued product if
`that discontinued drug product does not contain the same active ingredients.
`
`b. Phonetic and Orthographic Computer Analysis (POCA): Following the preliminary
`screening of the proposed proprietary name, DMEPA staff evaluates the proposed name
`against potentially similar names. In order to identify names with potential similarity to
`the proposed proprietary name, DMEPA enters the proposed proprietary name in POCA
`and queries the name against the following drug reference databases, Drugs@fda,
`CernerRxNorm, and names in the review pipeline using a 55% threshold in POCA.
`DMEPA reviews the combined orthographic and phonetic matches and group the names
`into one of the following three categories:
`• Highly similar pair: combined match percentage score ≥70%.
`• Moderately similar pair: combined match percentage score ≥55% to ≤ 69%.
`• Low similarity: combined match percentage score ≤54%.
`
`Reference ID: 4237570
`
`7
`
`
`
`Using the criteria outlined in the check list (Table 3-5) that corresponds to each of the three
`categories (highly similar pair, moderately similar pair, and low similarity), DMEPA
`evaluates the name pairs to determine the acceptability or non-acceptability of a proposed
`proprietary name. The intent of these checklists is to increase the transparency and
`predictability of the safety determination of whether a proposed name is vulnerable to
`confusion from a look-alike or sound-alike perspective. Each bullet below corresponds to the
`name similarity category cross-references the respective table that addresses criteria that
`DMEPA uses to determine whether a name presents a safety concern from a look-alike or
`sound-alike perspective.
` For highly similar names, differences in product characteristics often cannot mitigate the
`risk of a medication error, including product differences such as strength and dose. Thus,
`proposed proprietary names that have a combined score of ≥ 70 percent are at risk for a
`look-alike sound-alike confusion which is an area of concern (See Table 3).
` Moderately similar names are further evaluated to identify the presence of attributes that
`are known to cause name confusion.
` Name attributes: We note that the beginning of the drug name plays a
`significant role in contributing to confusion. Additionally, drug name pairs
`that start with the same first letter and contain a shared letter string of at
`least 3 letters in both names are major contributing factor in the confusion
`of drug namesf. We evaluate all moderately similar names retrieved from
`POCA to identify the above attributes. These names are further evaluated
`to identify overlapping or similar strengths or doses.
` Product attributes: Moderately similar names of products that have
`overlapping or similar strengths or doses represent an area for concern for
`FDA. The dose and strength information is often located in close
`proximity to the drug name itself on prescriptions and medication orders,
`and the information can be an important factor that either increases or
`decreases the potential for confusion between similarly named drug pairs.
`The ability of other product characteristics to mitigate confusion (e.g.,
`route, frequency, dosage form) may be limited when the strength or dose
`overlaps. DMEPA reviews such names further, to determine whether
`sufficient differences exist to prevent confusion. (See Table 4).
` Names with low similarity that have no overlap or similarity in strength and dose are
`generally acceptable (See Table 5) unless there are data to suggest that the name might be
`vulnerable to confusion (e.g., prescription simulation study suggests that the name is
`likely to be misinterpreted as a marketed product). In these instances, we would reassign
`a low similarity name to the moderate similarity category and review according to the
`moderately similar name pair checklist.
`
`f Shah, M, Merchant, L, Characteristics That May Help in the Identification of Potentially Confusing Proprietary
`Drug Names. Therapeutic Innovation & Regulatory Science, September 2016
`
`Reference ID: 4237570
`
`8
`
`
`
`c. FDA Prescription Simulation Studies: DMEPA staff also conducts a prescription
`simulation studies using FDA health care professionals.
`Three separate studies are conducted within the Centers of the FDA for the proposed
`proprietary name to determine the degree of confusion of the proposed proprietary name
`with marketed U.S. drug names (proprietary and established) due to similarity in visual
`appearance with handwritten prescriptions or verbal pronunciation of the drug name. The
`studies employ healthcare professionals (pharmacists, physicians, and nurses), and
`attempts to simulate the prescription ordering process. The primary Safety Evaluator
`uses the results to identify orthographic or phonetic vulnerability of the proposed name to
`be misinterpreted by healthcare practitioners.
`In order to evaluate the potential for misinterpretation of the proposed proprietary name
`in handwriting and verbal communication of the name, inpatient medication orders and/or
`outpatient prescriptions are written, each consisting of a combination of marketed and
`unapproved drug products, including the proposed name. These orders are optically
`scanned and one prescription is delivered to a random sample of participating health
`professionals via e-mail. In addition, a verbal prescription is recorded on voice mail.
`The voice mail messages are then sent to a random sample of the participating health
`professionals for their interpretations and review. After receiving either the written or
`verbal prescription orders, the participants record their interpretations of the orders which
`are recorded electronically.
`d. Comments from Other Review Disciplines: DMEPA requests the Office of New Drugs
`(OND) and/or Office of Generic Drugs (OGD), ONDQA or OBP for their comments or
`concerns with the proposed proprietary name, ask for any clinical issues that may impact
`the DMEPA review during the initial phase of the name review. Additionally, when
`applicable, at the same time DMEPA requests concurrence/non-concurrence with
`OPDP’s decision on the name. The primary Safety Evaluator addresses any comments or
`concerns in the safety evaluator’s assessment.
`The OND/OGD Regulatory Division is contacted a second time following our analysis of
`the proposed proprietary name. At this point, DMEPA conveys their decision to accept
`or reject the name. The OND or OGD Regulatory Division is requested to provide any
`further information that might inform DMEPA’s final decision on the proposed name.
`Additionally, other review disciplines opinions such as ONDQA or OBP may be
`considered depending on the proposed proprietary name.
`When provided, DMEPA considers external proprietary name studies conducted by or for
`the Applicant/Sponsor and incorporates the findings of these studies into the overall risk
`assessment.
`The DMEPA primary reviewer assigned to evaluate the proposed proprietary name is responsible
`for considering the collective findings, and provides an overall risk assessment of the proposed
`proprietary name.
`
`Reference ID: 4237570
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`9
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`
`
`Table 3. Highly Similar Name Pair Checklist (i.e., combined Orthographic and Phonetic
`score is ≥ 70%).
`Answer the questions in the checklist below. Affirmative answers to some of these
`questions suggest that the pattern of orthographic or phonetic differences in the names
`may render the names less likely to confusion, provided that the pair does not share a
`common strength or dose.
`
`Orthographic Checklist
`Y/N Do the names begin with different
`first letters?
`Note that even when names begin with
`different first letters, certain letters may be
`confused with each other when scripted.
`Y/N Are the lengths of the names
`dissimilar* when scripted?
`*FDA considers the length of names
`different if the names differ by two or more
`letters.
`Y/N Considering variations in scripting of
`some letters (such as z and f), is there
`a different number or placement of
`upstroke/downstroke letters present
`in the names?
`Y/N Is there different number or
`placement of cross-stroke or dotted
`letters present in the names?
`Y/N Do the infixes of the name appear
`dissimilar when scripted?
`Y/N Do the suffixes of the names appear
`dissimilar when scripted?
`
`Phonetic Checklist
`Y/N Do the names have different
`number of syllables?
`
`Y/N Do the names have different
`syllabic stresses?
`
`Y/N Do the syllables have different
`phonologic processes, such
`vowel reduction, assimilation,
`or deletion?
`
`Y/N Across a range of dialects, are
`the names consistently
`pronounced differently?
`
`Reference ID: 4237570
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`10
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`
`
`Table 4: Moderately Similar Name Pair Checklist (i.e., combined score is ≥55% to ≤69%).
`Step 1 Review the DOSAGE AND ADMINISTRATION and HOW
`SUPPLIED/STORAGE AND HANDLING sections of the prescribing
`information (or for OTC drugs refer to the Drug Facts label) to determine if
`strengths and doses of the name pair overlap or are very similar. Different
`strengths and doses for products whose names are moderately similar may
`decrease the risk of confusion between the moderately similar name pairs. Name
`pairs that have overlapping or similar strengths or doses have a higher potential
`for confusion and should be evaluated further (see Step 2). Because the strength
`or dose could be used to express an order or prescription for a particular drug
`product, overlap in one or both of these components would be reason for further
`evaluation.
`For single strength products, also consider circumstances where the strength may
`not be expressed.
`For any i.e. drug products comprised of more than one active ingredient,
`consider whether the strength or dose may be expressed using only one of the
`components.
`To determine whether the strengths or doses are similar to your proposed
`product, consider the following list of factors that may increase confusion:
` Alternative expressions of dose: 5 mL may be listed in the prescribing
`information, but the dose may be expressed in metric weight (e.g., 500
`mg) or in non-metric units (e.g., 1 tsp, 1 tablet/capsule). Similarly, a
`strength or dose of 1000 mg may be expressed, in practice, as 1 g, or vice
`versa.
`
` Trailing or deleting zeros: 10 mg is similar in appearance to 100 mg
`which may potentiate confusion between a name pair with moderate
`similarity.
`
` Similar sounding doses: 15 mg is similar in sound to 50 mg
`
`Step 2 Answer the questions in the checklist below. Affirmative answers to some of
`these questions suggest that the pattern of orthographic or phonetic differences in
`the names may reduce the likelihood of confusion for moderately similar names
`with overlapping or similar strengths or doses.
`
`Reference ID: 4237570
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`11
`
`
`
`Phonetic Checklist (Y/N to each
`question)
` Do the names have
`different number of
`syllables?
` Do the names have
`different syllabic stresses?
` Do the syllables have
`different phonologic
`processes, such vowel
`reduction, assimilation, or
`deletion?
` Across a range of dialects,
`are the names consistently
`pronounced differently?
`
`Orthographic Checklist (Y/N to each
`question)
` Do the names begin with different
`first letters?
`Note that even when names begin with
`different first letters, certain letters may be
`confused with each other when scripted.
` Are the lengths of the names
`dissimilar* when scripted?
`*FDA considers the length of names
`different if the names differ by two or
`more letters.
` Considering variations in scripting
`of some letters (such as z and f), is
`there a different number or
`placement of upstroke/downstroke
`letters present in the names?
`Is there different number or
`placement of cross-stroke or dotted
`letters present in the names?
` Do the infixes of the name appear
`dissimilar when scripted?
` Do the suffixes of the names appear
`dissimilar when scripted?
`
`
`
`Table 5: Low Similarity Name Pair Checklist (i.e., combined score is ≤54%).
`Names with low similarity are generally acceptable unless there are data to suggest that
`the name might be vulnerable to confusion (e.g., prescription simulation study suggests
`that the name is likely to be misinterpreted as a marketed product). In these instances,
`we would reassign a low similarity name to the moderate similarity category and
`review according to the moderately similar name pair checklist.
`
`Reference ID: 4237570
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`12
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`
`
`Appendix B: Prescription Simulation Samples and Results
`Figure 1. Tibsovo Study (Conducted on January 19, 2018)
`
`Handwritten Medication Order/Prescription
`
`Medication Order:
`
`Outpatient Prescription:
`
`Verbal
`Prescription
`Tibsovo 250 mg
`Take 2 tablets by
`mouth once daily
`Dispense #60
`
`FDA Prescription Simulation Responses (Aggregate 1 Rx Studies Report)
`296 People Received Study
`85 People Responded
`
`Study Name: Tibsovo
`As of February 27, 2018
`Total
`INTERPRETATION
`
`TESOVO
`
`TIBSOVO
`
`TIBXOVO
`
`TICKSOVO
`
`TIKSOVO
`
`TILZOVO
`
`31
`OUTPATIENT
`
`30
`VOICE
`
`24
`INPATIENT
`
`TOTAL
`
`0
`
`29
`
`1
`
`0
`
`1
`
`0
`
`1
`
`1
`
`0
`
`1
`
`0
`
`0
`
`0
`
`22
`
`0
`
`0
`
`0
`
`1
`
`1
`
`52
`
`1
`
`1
`
`1
`
`1
`
`Reference ID: 4237570
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`13
`
`
`
`TIPPOZO
`
`TIPSOBO
`
`TIPSOVO
`
`TIPZOVO
`
`TISOVO
`
`TYPSOVO
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`1
`
`1
`
`21
`
`2
`
`0
`
`2
`
`0
`
`0
`
`0
`
`0
`
`1
`
`0
`
`1
`
`1
`
`21
`
`2
`
`1
`
`2
`
`Reference ID: 4237570
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`
`
`
`Appendix C: Highly Similar Names (e.g., combined POCA score is ≥70%)
`N/A
`
`Appendix D: Moderately Similar Names (e.g., combined POCA score is ≥55% to ≤69%) with
`no overlap or numerical similarity in Strength and/or Dose
`N/A
`
`Appendix E: Moderately Similar Names (e.g., combined POCA score is ≥55% to ≤69%) with
`overlap or numerical similarity in Strength and/or Dose
`No.
`Proposed name: Tibsovo
`POCA
`Established name: ivosidenib
`Score (%)
`Dosage form: tablet
`Strength(s): 250 mg
`Usual Dose: 500 mg (2 tablets)
`once daily
`***
`
`1.
`
`61
`
`Prevention of Failure Mode
`
`In the conditions outlined below, the
`following combination of factors, are
`expected to minimize the risk of confusion
`between these two names
`This name pair has sufficient orthographic and
`phonetic differences.
`
`2.
`
`***
`
`58
`
`This name pair has sufficient orthographic and
`phonetic differences.
`
`3.
`
`4.
`
`***
`
`***
`
`56
`
`53
`
`This name pair has sufficient orthographic and
`phonetic differences.
`This name pair has sufficient orthographic and
`phonetic differences.
`
`Reference ID: 4237570
`
`15
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`
`
`Appendix F: Low Similarity Names (e.g., combined POCA score is ≤54%)
`No.
`Name
`POCA
`Score (%)
`46
`Symtuza***
`5.
`Appendix G: Names not likely to be confused or not used in usual practice settings for the
`reasons described.
`N/A
`
`Appendix H: Names not likely to be confused due to absence of attributes that are known to
`cause name confusion.g
`No.
`Name
`
`6.
`7.
`
`***
`***
`
`POCA
`Score (%)
`62
`56
`
`g Shah, M, Merchant, L, Chan, I, and Taylor, K. Characteristics That May Help in the Identification of Potentially
`Confusing Proprietary Drug Names. Therapeutic Innovation & Regulatory Science, September 2016
`
`Reference ID: 4237570
`
`16
`
`(b) (4)
`
`(b) (4)
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`SUSAN RIMMEL
`03/21/2018
`
`HINA S MEHTA
`03/21/2018
`
`Reference ID: 4237570
`
`