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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 022341/S-021
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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: Robert B. Clark
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` VP 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 Mr. Clark:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received
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`October 10, 2013, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
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`(FDCA) for Victoza (liraglutide [rNDA origin] injection).
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`We acknowledge receipt of your amendments dated March 26, May 12, June 13, July 1, 14, and
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`24, 2014.
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`This supplemental new drug application provides for proposed modifications to the approved
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`risk evaluation and mitigation strategy (REMS) for Victoza to modify the communication plan to
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`include additional communications for healthcare providers that address the potential risk of
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`medullary thyroid carcinoma and the risk of acute pancreatitis. This supplement is in response to
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`our REMS Modification Notification letter dated August 14, 2013.
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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 was originally approved on January 25, 2010, and was last modified on
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`May 18, 2011. The REMS consists of a communication plan and a timetable for submission of
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`assessments of the REMS. Your proposed modifications to the REMS consist of:
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`1. Revision of the REMS goal statement
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`2. Revision of the Communication Plan
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`• Replacement of the Dear Healthcare Provider letter with a REMS Letter for
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`Healthcare Providers and a REMS Letter for Professional Societies
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`• Addition of a REMS Factsheet
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`• Addition of REMS Slides
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`Reference ID: 3602528
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` NDA 022341/S-021
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` Page 2
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` • Dissemination of REMS information at scientific meetings
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` • Revision of the Victoza REMS website to reflect the aforementioned changes
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`3. Revision of the timetable for submission of REMS assessments
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` 4. Revision of REMS assessment plan
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`Your proposed modified REMS, submitted on July 24, 2014, and appended to this letter, is
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`approved.
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`The revised REMS assessment plan should include, but is not limited to the following:
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`a. An evaluation of the implementation of REMS Communication Plan activities:
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`i. Launch date of revised communication plan
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`ii. Number of HCPs and professional societies targeted by the REMS.
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`iii. REMS Letter: Number of REMS letters sent to HCPs and Professional Societies
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`via US mail (or email if this method is added) and the dates the letters were sent.
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`Number of letters that were undeliverable will be included. Provide a list of
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`names of professional societies with date of confirmed REMS letter receipt,
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`along with any actions taken (e.g., posting on societies website, other outreach to
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`members regarding REMS letters).
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`iv. REMS Factsheet: number of HCPs detailed and provided the REMS Factsheet
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`through the detail.
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`v. REMS Slides: number of presentations employing the REMS Slides during the
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`reporting period and cumulatively and number of attendees (including targeted
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`physicians).
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`vi. Scientific meetings: list of scientific meetings where Novo Nordisk Medical
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`Information has a presence (e.g., booth) in which the Victoza REMS Factsheet
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`was made available.
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`vii. REMS website: Date when the revised REMS website went live and number of
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`unique site visits during the assessment period and cumulative.
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`b. Evaluation of HCPs knowledge
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`i. An evaluation of HCPs’ knowledge of potential risk of medullary thyroid
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`carcinoma and the risk of acute pancreatitis (including necrotizing
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`pancreatitis) associated with Victoza. Stratify results by type of HCP
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`(general/family/internal medicine).
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`ii. An evaluation of prescribers’ awareness of REMS materials.
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`iii. An evaluation of prescribers’ sources of knowledge about the risks associated
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`with Victoza.
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`c. Safety Surveillance and Utilization Data for the reporting period and cumulatively
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`i. Victoza total prescription data by HCP target (PCP/IM, NP/PA, OBGYN,
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`Other).
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`Reference ID: 3602528
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` NDA 022341/S-021
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` Page 3
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` ii. A summary and analysis of all postmarketing case reports of (a) pancreatitis and
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` (b) medullary thyroid carcinoma.
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` d. Evaluation of the extent to which the elements of the REMS are meeting the goals and
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` objectives of the REMS and whether modifications to the elements or goals and
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` objectives are needed.
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`In addition to the assessments submitted according to the timetable included in the approved
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` REMS, you must submit a REMS assessment when you submit a supplemental application for a
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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
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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 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 the 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
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`PROPOSED REMS MODIFICATION
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` NEW SUPPLEMENT (NEW INDICATION FOR USE)
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` FOR NDA 022341
` REMS ASSESSMENT
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` PROPOSED REMS MODIFICATION (if included)
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`Reference ID: 3602528
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` NDA 022341/S-021
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` Page 4
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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, please call Pooja Dharia, Pharm.D., Regulatory Project Manager, at
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`(301) 796-5332.
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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 (Acting)
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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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`REMS
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`Reference ID: 3602528
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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
`07/31/2014
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`Reference ID: 3602528
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