NDA 203441/S-019
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`SUPPLEMENT APPROVAL
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`
`Shire-NPS Pharmaceuticals, Inc.
`Attention: Denzel Ngoma
`Senior Manager, Global Regulatory Strategy, GI
`40 Landsdowne Street
`Cambridge, MA 02139
`
`
`Dear Mr. Ngoma:
`
`Please refer to your supplemental New Drug Application (sNDA), dated and received on
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`May 15, 2020, and your amendments, submitted under section 505(b) of the Federal
`Food, Drug, and Cosmetic Act (FD&C Act) for Gattex (teduglutide) for injection, 5 mg.
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`This Changes Being Effected sNDA provides for a proposed modification to the
`approved Gattex risk evaluation and mitigation strategy (REMS). We have completed
`our review of this supplemental application, as amended, and it is approved effective on
`the date of this letter.
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`RISK EVALUATION AND MITIGATION STRATEGY (REMS) REQUIREMENTS
`
`
`The REMS for Gattex (teduglutide) was originally approved on December 21, 2012, and
`the most recent REMS modification was approved on May 16, 2019. The REMS
`consists of elements to assure safe use and a timetable for submission of assessments
`of the REMS. Your proposed modification to the REMS consists of providing a link to
`the healthcare provider survey on the Gattex REMS website.
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`Your proposed modified REMS, submitted and received on June 24, 2020, and
`appended to this letter, is approved. The timetable for submission of assessments of the
`REMS remains the same as that approved on December 21, 2012. There are no
`changes to the REMS assessment plan described in our May 16, 2019 letter.
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`We remind you that in addition to the REMS assessments submitted according to the
`timetable in the approved REMS, you must include an adequate rationale to support a
`proposed REMS modification for the addition, modification, or removal of any goal or
`element of the REMS, as described in section 505-1(g)(4) of the FD&C Act.
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`We also remind you that you must submit a REMS assessment when you submit a
`supplemental application for a new indication for use, as described in section 505-
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` 1(g)(2)(A) of the FD&C Act. This assessment should include:
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`Reference ID: 4640332
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`NDA 203441/S-019
`Page 2
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`f.
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`a. An evaluation of how the benefit-risk profile will or will not change with the new
`indication.
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`b. A determination of the implications of a change in the benefit-risk profile for the
`current REMS.
`c. If the new indication for use introduces unexpected risks: A description of those
`risks and an evaluation of whether those risks can be appropriately managed
`with the currently approved REMS.
`d. If a REMS assessment was submitted in the 18 months prior to submission of the
`supplemental application for a new indication for use: A statement about whether
`the REMS was meeting its goals at the time of that last assessment and if any
`modifications of the REMS have been proposed since that assessment.
`e. If a REMS assessment has not been submitted in the 18 months prior to
`submission of the supplemental application for a new indication for use: Provision
`of as many of the currently listed assessment plan items as is feasible.
`If you propose a REMS modification based on a change in the benefit-risk profile
`or because of the new indication of use, submit an adequate rationale to support
`the modification, including: Provision of the reason(s) why the proposed REMS
`modification is necessary, the potential effect on the serious risk(s) for which the
`REMS was required, on patient access to the drug, and/or on the burden on the
`health care delivery system; and other appropriate evidence or data to support
`the proposed change. Additionally, include any changes to the assessment plan
`necessary to assess the proposed modified REMS. If you are not proposing
`REMS modifications, provide a rationale for why the REMS does not need to be
`modified.
`
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`If the assessment instruments and methodology for your REMS assessments are not
`included in the REMS supporting document, or if you propose changes to the submitted
`assessment instruments or methodology, you should update the REMS supporting
`document to include specific assessment instrument and methodology information at
`least 90 days before the assessments will be conducted. Updates to the REMS
`supporting document may be included in a new document that references previous
`REMS supporting document submission(s) for unchanged portions. Alternatively,
`updates may be made by modifying the complete previous REMS supporting document,
`with all changes marked and highlighted. Prominently identify the submission containing
`the assessment instruments and methodology with the following wording in bold capital
`letters at the top of the first page of the submission:
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`NDA 203441 REMS ASSESSMENT METHODOLOGY
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`(insert concise description of content in bold capital letters, e.g.,
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`ASSESSMENT METHODOLOGY, PROTOCOL, SURVEY METHODOLOGIES,
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`AUDIT PLAN, DRUG USE STUDY)
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`An authorized generic drug under this NDA must have an approved REMS prior to
`marketing. Should you decide to market, sell, or distribute an authorized generic drug
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` U.S. Food and Drug Administration
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` Silver Spring, MD 20993
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` www.fda.gov
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`Reference ID: 4640332
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`

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`NDA 203441/S-019
`Page 3
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`under this NDA, contact us to discuss what will be required in the authorized generic
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`drug REMS submission.
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`We remind you that section 505-1(f)(8) of FD&C Act prohibits holders of an approved
`covered application with elements to assure safe use from using any element to block
`or delay approval of an application under section 505(b)(2) or (j). A violation of this
`provision in 505-1(f) could result in enforcement action.
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`Prominently identify any submission containing the REMS assessments or proposed
`modifications of the REMS with the following wording in bold capital letters at the top of
`the first page of the submission as appropriate:
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`NDA 203441 REMS ASSESSMENT
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`or
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`NEW SUPPLEMENT FOR NDA 203441/S-XXX
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`CHANGES BEING EFFECTED IN 30 DAYS
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`PROPOSED MINOR REMS MODIFICATION
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`or
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`NEW SUPPLEMENT FOR NDA 203441/S-XXX
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`PRIOR APPROVAL SUPPLEMENT
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`PROPOSED MAJOR REMS MODIFICATION
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`or
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`NEW SUPPLEMENT FOR NDA 203441/S-XXX
`PRIOR APPROVAL SUPPLEMENT
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`PROPOSED REMS MODIFICATIONS DUE TO SAFETY LABEL CHANGES
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`SUBMITTED IN SUPPLEMENT YYY
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`or
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`NEW SUPPLEMENT (NEW INDICATION FOR USE)
`FOR NDA 203441/S-XXX
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`REMS ASSESSMENT
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`PROPOSED REMS MODIFICATION (if included)
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`Should you choose to submit a REMS revision, prominently identify the submission
`containing the REMS revisions with the following wording in bold capital letters at the
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`top of the first page of the submission:
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`
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` U.S. Food and Drug Administration
`
` Silver Spring, MD 20993
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` www.fda.gov
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`REMS REVISIONS FOR NDA 203441
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`
`
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`Reference ID: 4640332
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`

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`NDA 203441/S-019
`Page 4
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`To facilitate review of your submission, we request that you submit your proposed
`modified REMS and other REMS-related materials in Microsoft (MS) Word format. If
`certain documents, such as enrollment forms, or website screenshots are only in PDF
`format, they may be submitted as such, but MS Word format is preferred.
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`SUBMISSION OF REMS DOCUMENT IN SPL FORMAT
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`FDA can accept the REMS document in Structured Product Labeling (SPL) format. If
`you intend to submit the REMS document in SPL format, as soon as possible, but no
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`later than 14 days from the date of this letter, submit the REMS document in SPL format
`using the FDA automated drug registration and listing system (eLIST).
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`For more information on submitting REMS in SPL format, please email
`FDAREMSwebsite@fda.hhs.gov.
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`REPORTING REQUIREMENTS
`
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`If you have any questions, contact Benjamin Vali, Regulatory Health Project Manager,
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`at (301) 796-4261 or benjamin.vali@fda.hhs.gov.
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`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`Jessica J. Lee, M.D., M.M.Sc.
`Director (Acting)
`Division of Gastroenterology
`Office of Immunology and Inflammation
`Center for Drug Evaluation and Research
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`
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`Enclosure:
` REMS
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` U.S. Food and Drug Administration
`
` Silver Spring, MD 20993
`
` www.fda.gov
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`Reference ID: 4640332
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`

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`Signature Page 1 of 1
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`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
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`/s/
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`JESSICA J LEE
`07/14/2020 10:29:29 AM
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`Reference ID: 4640332
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