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`( ..lff!._ DEPARTMENT OF HEALTH AND HUMAN SERVICES
`•+,~~t._
`~...(J
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`NDA 206321/S-002
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`Novo Nordisk, Inc.
`Attention: Michelle Thompson
`Senior Director, Regulato1y Affairs
`P.O. Box 846
`800 Scudders Mill Road
`Plainsboro, NJ 08536
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`Dear Ms. Thompson:
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Please refer to your supplemental New Drng Application (sNDA) dated and received
`December 3, 2015, submitted under section 505(b) of the Federal Food, Drng, and Cosmetic Act
`(FDCA) for Saxenda (liraglutide [ rDNA origin] injection), 3 mg.
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`This "Changes Being Effected" supplemental new diug application proposed modifications to
`the approved Saxenda REMS.
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`We have completed our review of this supplemental application, as amended. It is approved, as
`further described in this communication, effective on the date of this letter.
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`RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS
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`The REMS for Saxenda was originally approved on December 23, 2014. The REMS consists of
`a communication plan and a timetable for submission of assessments of the REMS. Your
`(b)(~~; however, we
`proposed modification to the REMS consisted o1
`refer to our communication dated Januaiy 28, 2016, m which we mfo1med you that FDA does
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`not agree with your December 3, 2015, P,!9POsal
`(b) <
`The initial REMS document approved
`on December 23, 2014 included www.saxenda.com as the website that would contain the link to
`the Saxenda REMS webpage, www.saxenda.com/REMS. On Januaiy 14, 2016, FDA evaluated
`the landing page and links on the consumer/product website for Saxenda (www.saxenda.com).
`The www.saxenda.com website cmTently has a link to the REMS website and a link to
`www.saxendapro.com. This approach (containing a link to the REMS website on both
`www.saxenda.com and www.saxendapro.com) is acceptable to the FDA, and therefore this
`website should remain as it cmTently presents. We also acknowledge your Januaiy 29, 2016,
`submission in which you propose an additional consumer/product website,
`www.saxendacare.com. The addition of this website, which also contains a link to the REMS
`website, is acceptable. However, modifications to the REMS document were necessary for
`consistency with the presentation of the cmTent consumer/product websites.
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`Reference ID: 3880807
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` NDA 206321/S-002
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` Page 2
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` Your proposed modified REMS, submitted on January 29, 2016, and appended to this letter, is
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` approved. Specifically, FDA approves your approach to include a link to the Saxenda REMS
` website on www.saxenda.com, www.saxendacare.com, and www.saxendapro.com.
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` The timetable for submission of assessments of the REMS remains the same as that approved on
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` December 23, 2014.
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`There are no changes to the REMS assessment plan described in our December 23, 2014, letter.
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`We remind you that in addition to the REMS assessments submitted according to the timetable in
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`the approved REMS, you must include an adequate rationale to support a proposed REMS
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`modification for the addition, modification, or removal of any goal or element of the REMS, as
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`described in section 505-1(g)(4) of the FDCA.
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`We also remind you that you must submit a REMS assessment when you submit a supplemental
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`application for a new indication for use as described in section 505-1(g)(2)(A) of the FDCA.
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`This assessment should include:
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`a) An evaluation of how the benefit-risk profile will or will not change with the new
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`indication;
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`b) A determination of the implications of a change in the benefit-risk profile for the current
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`REMS;
`If the new indication for use introduces unexpected risks: A description of those risks
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`and an evaluation of whether those risks can be appropriately managed with the currently
`approved REMS.
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`If a REMS assessment was submitted in the 18 months prior to submission of the
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`supplemental application for a new indication for use: A statement about whether the
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`REMS was meeting its goals at the time of that last assessment and if any modifications
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`of the REMS have been proposed since that assessment.
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`If a REMS assessment has not been submitted in the 18 months prior to submission of the
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`supplemental application for a new indication for use: Provision of as many of the
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`currently listed assessment plan items as is feasible.
`If you propose a REMS modification based on a change in the benefit-risk profile or
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`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
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`modification is necessary; the potential effect on the serious risk(s) for which the REMS
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`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.
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`Additionally, include any changes to the assessment plan necessary to assess the
`proposed modified REMS. If you are not proposing REMS modifications, provide a
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`rationale for why the REMS does not need to be modified.
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`c)
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`d)
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`e)
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`f)
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`If the assessment instruments and methodology for your REMS assessments are not included in
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`the REMS supporting document, or if you propose changes to the submitted assessment
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`instruments or methodology, you should update the REMS supporting document to include
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`specific assessment instrument and methodology information at least 90 days before the
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`Reference ID: 3880807
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` NDA 206321/S-002
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` Page 3
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` assessments will be conducted. Updates to the REMS supporting document may be included in a
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` new document that references previous REMS supporting document submission(s) for
` unchanged portions. Alternatively, updates may be made by modifying the complete previous
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` REMS supporting document, with all changes marked and highlighted. Prominently identify the
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` submission containing the assessment instruments and methodology with the following wording
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` in bold capital letters at the top of the first page of the submission:
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`NDA 206321 REMS CORRESPONDENCE
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`(insert concise description of content in bold capital letters, e.g.,
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`UPDATE TO REMS SUPPORTING DOCUMENT - ASSESSMENT
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`METHODOLOGY
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`An authorized generic drug under this NDA must have an approved REMS prior to marketing.
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`Should you decide to market, sell, or distribute an authorized generic drug under this NDA,
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`contact us to discuss what will be required in the authorized generic drug REMS submission.
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`Prominently identify any submission containing the REMS assessments or proposed
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`modifications of the REMS with the following wording in bold capital letters at the top of the
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`first page of the submission as appropriate:
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`NDA 206321 REMS ASSESSMENT
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`NEW SUPPLEMENT FOR NDA 206321/S-000
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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 206321/S-000
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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 206321/S-000
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`PRIOR APPROVAL SUPPLEMENT
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`PROPOSED REMS MODIFICATIONS DUE TO SAFETY LABEL CHANGES
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`SUBMITTED IN SUPPLEMENT XXX
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` or
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` NEW SUPPLEMENT (NEW INDICATION FOR USE)
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` FOR NDA 206321/S-000
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` REMS ASSESSMENT
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` PROPOSED REMS MODIFICATION (if included)
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`Reference ID: 3880807
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`REMS REVISIONS FOR NDA 206321
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` NDA 206321/S-002
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` Page 4
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` Should you choose to submit a REMS revision, prominently identify the submission containing
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` the REMS revisions with the following wording in bold capital letters at the top of the first page
` of the submission:
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`To facilitate review of your submission, we request that you submit your proposed modified
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`REMS and other REMS-related materials in Microsoft Word format. If certain documents, such
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`as enrollment forms, are only in PDF format, they may be submitted as such, but the preference
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`is to include as many as possible in Word format.
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`If you do not submit electronically, please send 5 copies of REMS-related submissions.
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
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`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Patricia Madara, Regulatory Project Manager, at (301) 796-1249.
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`Sincerely,
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`{See appended electronic signature page}
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`Jennifer Rodriguez Pippins, M.D., M.P.H.
`Deputy Director for Safety
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`Division of Metabolism and Endocrinology Products
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`Office of Drug Evaluation II
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`Center for Drug Evaluation and Research
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`ENCLOSURE:
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`REMS
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`Reference ID: 3880807
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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`JENNIFER R PIPPINS
`02/01/2016
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`Reference ID: 3880807
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