`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
` NDA 022341/S-021
`
`
`
`
`
`
`
`
`Food and Drug Administration
`
`
` Silver Spring MD 20993
`
`
`SUPPLEMENT APPROVAL
`
`
`
`
` Novo Nordisk, Inc.
`
` Attention: Robert B. Clark
`
` VP Regulatory Affairs
`
` P.O. Box 846
`
` 800 Scudders Mill Road
`
` Plainsboro, NJ 08536
`
`
`
`
`Dear Mr. Clark:
`
`
`
`
`
`
`
`
`Please refer to your Supplemental New Drug Application (sNDA) dated and received
`
`
`
`October 10, 2013, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
`
`
`(FDCA) for Victoza (liraglutide [rNDA origin] injection).
`
`
`
`
`We acknowledge receipt of your amendments dated March 26, May 12, June 13, July 1, 14, and
`
`24, 2014.
`
`
`
`This supplemental new drug application provides for proposed modifications to the approved
`
`
`risk evaluation and mitigation strategy (REMS) for Victoza to modify the communication plan to
`
`
`
`include additional communications for healthcare providers that address the potential risk of
`
`medullary thyroid carcinoma and the risk of acute pancreatitis. This supplement is in response to
`
`
`
`our REMS Modification Notification letter dated August 14, 2013.
`
`
`
`
`We have completed our review of this supplemental application, as amended. It is approved,
`
`effective on the date of this letter.
`
`
`
`RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS
`
`The REMS for Victoza was originally approved on January 25, 2010, and was last modified on
`
`
`
`
`May 18, 2011. The REMS consists of a communication plan and a timetable for submission of
`
`
`
`assessments of the REMS. Your proposed modifications to the REMS consist of:
`
`
`
`1. Revision of the REMS goal statement
`
`
`2. Revision of the Communication Plan
`
`
`• Replacement of the Dear Healthcare Provider letter with a REMS Letter for
`
`
`
`
`Healthcare Providers and a REMS Letter for Professional Societies
`
`
`
`
`• Addition of a REMS Factsheet
`
`
`• Addition of REMS Slides
`
`
`
`Reference ID: 3602528
`
`

`

`
`
` NDA 022341/S-021
`
` Page 2
`
`
`
`
`
`
`
` • Dissemination of REMS information at scientific meetings
`
` • Revision of the Victoza REMS website to reflect the aforementioned changes
`
`3. Revision of the timetable for submission of REMS assessments
`
`
` 4. Revision of REMS assessment plan
`
`
`
`
`
`Your proposed modified REMS, submitted on July 24, 2014, and appended to this letter, is
`
`approved.
`
`
`
`
`The revised REMS assessment plan should include, but is not limited to the following:
`
`
`
`
`
`
`
`
`
`
`a. An evaluation of the implementation of REMS Communication Plan activities:
`
`
`
`
`
`
`
`i. Launch date of revised communication plan
`
`
`
`
`
`
`
`
`
`
`
`ii. Number of HCPs and professional societies targeted by the REMS.
`
`
`
`
`
`
`
`
`
`
`
`
`iii. REMS Letter: Number of REMS letters sent to HCPs and Professional Societies
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`via US mail (or email if this method is added) and the dates the letters were sent.
`
`
`
`
`
`
`
`
`
`
`
`
`
`Number of letters that were undeliverable will be included. Provide a list of
`
`
`
`
`
`
`
`
`
`
`
`names of professional societies with date of confirmed REMS letter receipt,
`
`
`
`
`
`
`
`
`
`
`
`
`along with any actions taken (e.g., posting on societies website, other outreach to
`
`
`
`
`members regarding REMS letters).
`
`
`
`
`
`
`
`
`
`
`
`iv. REMS Factsheet: number of HCPs detailed and provided the REMS Factsheet
`
`
`
`
`through the detail.
`
`
`
`
`
`
`
`
`
`
`v. REMS Slides: number of presentations employing the REMS Slides during the
`
`
`
`
`
`
`
`
`
`
`reporting period and cumulatively and number of attendees (including targeted
`
`physicians).
`
`
`
`
`
`
`
`
`
`
`vi. Scientific meetings: list of scientific meetings where Novo Nordisk Medical
`
`
`
`
`
`
`
`
`
`
`
`Information has a presence (e.g., booth) in which the Victoza REMS Factsheet
`
`
`
`was made available.
`
`
`
`
`
`
`
`
`
`
`
`
`
`vii. REMS website: Date when the revised REMS website went live and number of
`
`
`
`
`
`
`
`
`
`
`unique site visits during the assessment period and cumulative.
`
`
`
`
`b. Evaluation of HCPs knowledge
`
`
`
`
`
`
`
`
`
`
`i. An evaluation of HCPs’ knowledge of potential risk of medullary thyroid
`
`
`
`
`
`
`carcinoma and the risk of acute pancreatitis (including necrotizing
`
`
`
`
`
`
`
`
`pancreatitis) associated with Victoza. Stratify results by type of HCP
`
`
`(general/family/internal medicine).
`
`
`
`
`
`
`
`
`ii. An evaluation of prescribers’ awareness of REMS materials.
`
`
`
`
`
`
`
`
`
`
`
`
`iii. An evaluation of prescribers’ sources of knowledge about the risks associated
`
`
`
`with Victoza.
`
`
`
`
`
`
`
`
`
`
`
`c. Safety Surveillance and Utilization Data for the reporting period and cumulatively
`
`
`
`
`
`
`
`
`
`
`i. Victoza total prescription data by HCP target (PCP/IM, NP/PA, OBGYN,
`
`
`Other).
`
`Reference ID: 3602528
`
`

`

`
`
` NDA 022341/S-021
`
` Page 3
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` ii. A summary and analysis of all postmarketing case reports of (a) pancreatitis and
`
` (b) medullary thyroid carcinoma.
`
`
`
`
`
`
`
`
`
`
`
` d. Evaluation of the extent to which the elements of the REMS are meeting the goals and
`
`
`
`
`
`
`
`
`
`
` objectives of the REMS and whether modifications to the elements or goals and
`
`
`
`
`
`
`
`
`
`
`
` objectives are needed.
`
`
`
`
`
`
`In addition to the assessments submitted according to the timetable included in the approved
`
` REMS, you must submit a REMS assessment when you submit a supplemental application for a
` new indication for use as described in section 505-1(g)(2)(A) of the FDCA.
`
`
`
`
`
`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:
`
`
`
`
`NDA 022341 REMS CORRESPONDENCE
`
`
`
`(insert concise description of content in bold capital letters, e.g.,
`
`
`UPDATE TO REMS SUPPORTING DOCUMENT - ASSESSMENT
`
`
`METHODOLOGY)
`
`
`
`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 under this NDA,
`
`contact us to discuss what will be required in the authorized generic drug REMS submission.
`
`
`
`
`Prominently identify the 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:
`
`
`
`
`NDA 022341 REMS ASSESSMENT
`
`
`
`NEW SUPPLEMENT FOR NDA 022341
`
`
`PROPOSED REMS MODIFICATION
`
`
` NEW SUPPLEMENT (NEW INDICATION FOR USE)
`
`
` FOR NDA 022341
` REMS ASSESSMENT
`
` PROPOSED REMS MODIFICATION (if included)
`
`
`
`
`
`Reference ID: 3602528
`
`

`

` NDA 022341/S-021
`
` Page 4
`
`
` REPORTING REQUIREMENTS
`
` We remind you that you must comply with reporting requirements for an approved NDA
`
`
`
` (21 CFR 314.80 and 314.81).
`
`
`
`
`
`If you have any questions, please call Pooja Dharia, Pharm.D., Regulatory Project Manager, at
`
`
`(301) 796-5332.
`
`
`
`
`
`
`
`
`
`Sincerely,
`
` {See appended electronic signature page}
`
`
`Jennifer Rodriguez Pippins, M.D., M.P.H.
`
`
`Deputy Director for Safety (Acting)
`
`Division of Metabolism and Endocrinology Products
`
`
`Office of Drug Evaluation II
`
`Center for Drug Evaluation and Research
`
`
`
`
`
`
`
`
`
`ENCLOSURES:
`
`REMS
`
`Reference ID: 3602528
`
`

`

`---------------------------------------------------------------------------------------------------------
`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
`07/31/2014
`
`Reference ID: 3602528
`
`