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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 022341/S-026
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` Food and Drug Administration
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` Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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` Novo Nordisk Inc.
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` Attention: Michelle Thompson
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` Senior Director, Regulatory Affairs
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` P.O. Box 846
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` 800 Scudders Mill Road
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` Plainsboro, NJ 08536
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`Dear Ms. Thompson:
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`Please refer to your supplemental New Drug Application (sNDA) dated and received
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`July 22, 2016, and your amendments, submitted under section 505(b) of the Federal Food, Drug,
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`and Cosmetic Act (FDCA) for Victoza (liraglutide) injection.
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`This “Changes Being Effected” supplemental new drug application provides for proposed
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`modifications to the approved REMS for Victoza (liraglutide). This supplement is in response to
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`our June 30, 2016, REMS Modification Notification letter.
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`We have completed our review of this supplemental application, as amended. It is approved,
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`effective on the date of this letter.
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`RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS
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`The REMS for Victoza (liraglutide) was originally approved on January 25, 2010, and was last
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`modified on July 1, 2015. The REMS consists of a communication plan and a timetable for
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`submission of assessments of the REMS. In order to ensure the benefits of Victoza (liraglutide)
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`outweigh its risks, we determined that you were required to make the following REMS
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`modification: a requirement to add a REMS-specific link on all Victoza (liraglutide) consumer
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`websites to improve healthcare providers’ access to the Victoza REMS.
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`Your proposed modified REMS, submitted on August 22, 2016, and appended to this letter, is
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`approved. The modified REMS consists of a communication plan and a timetable for
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`submission of assessments of the REMS.
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`The timetable for submission of assessments of the REMS remains the same as that approved on
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`July 31, 2014. There are no changes to the REMS assessment plan described in our
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`July 31, 2014, letter.
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`Reference ID: 3988085
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` NDA 022341/S-026
` Page 2
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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
`modification for the addition, modification, or removal of any of goal or element of the REMS,
`as 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;
` b) A determination of the implications of a change in the benefit-risk profile for the current
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` REMS;
` c) 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
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` approved REMS.
` d) 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 the last assessment and if any modifications
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` of the REMS have been proposed since that assessment.
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` e) 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.
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`f) 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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`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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`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
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` unchanged portions. Alternatively, updates may be made by modifying the complete previous
` 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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`Reference ID: 3988085
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` NDA 022341/S-026
` Page 3
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` NDA 022341 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 022341 REMS ASSESSMENT
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`NEW SUPPLEMENT FOR NDA 022341/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 022341/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 022341/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 022341/S-000
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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
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`the REMS revisions with the following wording in bold capital letters at the top of the first page
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`of the submission:
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`REMS REVISIONS FOR NDA 022341
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`Reference ID: 3988085
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` NDA 022341/S-026
` Page 4
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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
`as enrollment forms, are only in PDF format, they may be submitted as such, but the preference
`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 Marisa Petruccelli, Regulatory Project Manager, at
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` (240) 402-6147.
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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.
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` Deputy Director for Safety
` Division of Metabolism and Endocrinology Products
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` Office of Drug Evaluation II
` Center for Drug Evaluation and Research
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` ENCLOSURE:
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` REMS
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`Reference ID: 3988085
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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/
`----------------------------------------------------
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`JENNIFER R PIPPINS
`09/20/2016
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`Reference ID: 3988085
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`(
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