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Product Approval
Information - Licensing Action
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
June 27, 2003
Our STN Number: BL 103950/5013
Jeffrey N. Fellows
Amgen, Incorporated
One Amgen Center Drive
Thousand Oaks, CA 91320-1789
Dear Mr. Fellows:
Your request to supplement your biologics license application for Anakinra to revise the package insert to include information on an increased risk of serious infections when used with Etanercept and a revised definition of the threshold for neutropenia has been approved.
This supplement also addressed the following postmarketing commitments listed in the November 14, 2001, approval letter for BL 103950/0. The study numbers below correspond to the numbers used in the approval letter.
- To submit data from an ongoing study of the safety and efficacy of Anakinra in combination with Etanercept in patients with rheumatoid arthritis. The protocol for study 20000223, entitled “A Multicenter, Double-Blind Study to Evaluate the Safety and Efficacy of Anakinra and Etanercept in Subjects with Rheumatoid Arthritis using Methotrexate” was submitted to IND ---- on January 9, 2001. Patient accrual will be
completed by October 31, 2001, the study completed by April 31, 2002, and a final study report will be submitted by December 31, 2002.
- To conduct a multi-center, randomized, controlled study of 250 patients to evaluate the safety and efficacy of the combination of Etanercept and Anakinra, compared to Anakinra alone, in patients with rheumatoid arthritis. ACR response and the individual ACR components will be measured to assess efficacy. The safety profile of Anakinra and Etanercept will be assessed in this study with particular reference to the incidence of serious infections. This protocol will be submitted by October 31, 2002. Patient accrual will be completed by October 31, 2003, the study completed by April 30, 2004, and a final study report submitted by December 31, 2004.
Based on our review of the supplement, these studies should not be completed due to an increased risk of serious infections and no added clinical benefit associated with concurrent use of Etanercept. Therefore, you are released from the above commitments.
Pursuant to 21 CFR 201.57(f)(2), patient labeling must be reprinted at the end of the package insert. We request that the text of information distributed to patients be printed in a minimum of 10 point font.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide a PDF-format electronic copy as well as original paper copies (ten for circulars and five for other labels).
This information will be included in your biologics license application file. If you have any questions, call Victoria Tyson-Medlock, Regulatory Project Manager at 301-827-4358.
Sincerely yours,
--- signature ---
Patricia Keegan, M.D.
Acting Director
Division of Clinical Trials Design and Analysis
Office of Therapeutics Research and Review
Center for Biologics Evaluation and Research
Last Updated: 7/3/2003
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Date created: September 25, 2003 |
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