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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 022341/S-027
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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
` 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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` October 25, 2016, and your amendments, submitted under section 505(b) of the Federal Food,
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` Drug, and Cosmetic Act (FDCA) for Victoza (liraglutide) injection.
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` This Prior Approval supplemental new drug application proposes the addition of an indication to
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` reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and
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` established cardiovascular disease, and revised labeling to reflect the results of the “Liraglutide
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` Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results” (LEADER) trial.
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`APPROVAL & LABELING
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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, for use as recommended in the enclosed, agreed-upon labeling
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`text and with the minor editorial revisions listed below:
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`• Brackets were removed from the dates in the Recent Major Changes section of
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`Highlights.
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`• The version number and date of issue were updated on the final page of the Prescribing
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`Information.
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`CONTENT OF LABELING
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`As soon as possible, but no later than 14 days from the date of this letter, submit the content of
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`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
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`automated drug registration and listing system (eLIST), as described at
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
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`of labeling must be identical to the enclosed labeling (text for the prescribing information,
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`Medication Guide, and instructions for use), with the addition of any labeling changes in pending
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`Reference ID: 4144309
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` NDA 022341/S-027
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` Page 2
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` “Changes Being Effected” (CBE) supplements, as well as annual reportable changes not
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`included in the enclosed labeling.
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`Information on submitting SPL files using eList may be found in the guidance for industry titled
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`“SPL Standard for Content of Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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`The SPL will be accessible from publicly available labeling repositories.
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` Also within 14 days, amend all pending supplemental applications that include labeling changes
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` for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
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` with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
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` changes approved in this supplemental application, as well as annual reportable changes and
` annotate each change. To facilitate review of your submission, provide a highlighted or marked-
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` up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
` should provide appropriate annotations, including supplement number(s) and annual report
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`date(s).
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`REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
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`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
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`administration are required to contain an assessment of the safety and effectiveness of the
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`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
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`deferred, or inapplicable.
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`Because none of these criteria apply to your application, you are exempt from this requirement.
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`FULFILLMENT OF POSTMARKETING REQUIREMENT
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`This supplemental application contained the final report for the following postmarketing
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`requirement listed in the January 25, 2010, approval letter for NDA 022341.
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`1583-9 A randomized, double-blind, controlled trial evaluating the effect of Victoza
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`(liraglutide [rDNA origin]) injection on the incidence of major adverse
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`cardiovascular events in patients with type 2 diabetes mellitus. This trial must
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`also assess adverse events of interest including the long-term effects of Victoza
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`(liraglutide [rDNA origin]) injection on potential biomarkers of medullary thyroid
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`carcinoma (e.g., serum calcitonin) as well as the long-term effects of Victoza
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`(liraglutide [rDNA origin]) injection on pancreatitis, renal safety, serious
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`hypoglycemia, immunological reactions, and neoplasms.
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`We have reviewed your submission and conclude that the above requirement was fulfilled.
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`Reference ID: 4144309
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` NDA 022341/S-027
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` Page 3
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` We remind you that there are postmarketing requirements listed in the January 25, 2010,
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` approval letter that are still open.
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`PROMOTIONAL MATERIALS
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` You may request advisory comments on proposed introductory advertising and promotional
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` labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
` comments, (2) the proposed materials in draft or mock-up form with annotated references, and
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` (3) the package insert(s) to:
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`OPDP Regulatory Project Manager
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`Food and Drug Administration
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`Center for Drug Evaluation and Research
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`Office of Prescription Drug Promotion (OPDP)
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`5901-B Ammendale Road
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`Beltsville, MD 20705-1266
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`Alternatively, you may submit a request for advisory comments electronically in eCTD format.
`For more information about submitting promotional materials in eCTD format, see the draft
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`Guidance for Industry (available at:
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM443702.pdf ).
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`You must submit final promotional materials and package insert(s), accompanied by a Form
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`FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form
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`FDA 2253 is available at
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`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
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`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
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`more information about submission of promotional materials to the Office of Prescription Drug
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`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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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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`Reference ID: 4144309
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` NDA 022341/S-027
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` Page 4
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` Sincerely,
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`{See appended electronic signature page}
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`Jean-Marc Guettier, M.D.
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`Director
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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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`ENCLOSURES:
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`Prescribing Information
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`Medication Guide
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`Instructions for Use (version approved April 25, 2017)
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`Reference ID: 4144309
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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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`JEAN-MARC P GUETTIER
`08/25/2017
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`Reference ID: 4144309
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