Information - Licensing Action
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
MAY 27, 1999
Our Reference No.: 98-1296
Sally R. Gould
51 University Street
Seattle, WA 98101
Dear Ms. Gould:
Your request to supplement your biologic license application for Etanercept to expand the indication to include polyarticular course juvenile rheumatoid arthritis (JR4) has been approved.
We acknowledge your agreement to provide additional information and to conduct
postmarketing studies as described in your commitment letter of May 26, 1999, and as outlined below:
To collect safety and efficacy data on the long term use of Etanercept (Enbrel) in at least 500 JRA patients for a minimum of 3 years. The study will include detailed efficacy and safety data collection on 200 patients with more limited data collection in an additional 300 patients. A protocol for collecting these data will be submitted by August 31, 1999 and the study or registry initiated by April 1, 2000.
To perform a population pharmacolcinetics and safety study in JRA patients age [______] years. This study will be initiated by October, 1999.
To reanalyze the pharmacokinetic data using a modified dataset and validate a model proposed by the Agency, which includes the effect of the covariates of age and weight on the clearance parameter.
To submit a [____________________________________________________________ ________________________________________________________________________________ ________________________________________________________________________________ ________________________________________________________________________________ ____________________________________________________________________].
To initiate a study to evaluate the concurrent use of Enbrel and
methotrexate by October 1, 1999.
To retest patient samples from protocol 16.0016 with the modified ELISA assay for anti-Enbrel antibodies and to submit results of the new analysis by July 1, 1999.
In accordance with your commitment of November 2, 1998, to submit data on adult patient responses to immunizations by June 30, 1999.
To initiate a study of the effects of Enbrel in children with active systemic onset JRA by December 1, 1999.
Please submit three copies of final printed labeling at the time of use and include part II of the label transmittal form (FDA form 2567) with completed implementation information. In addition, you may wish to submit draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2567 or Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Staff, HFM-202, 1401 Rockville Pike, Rockville, MD 20852-1448. Final printed advertising and promotional labeling should be submitted at the time of initial dissemination, accompanied by a FDA Form 2567 or Form 2253.
All promotional claims must be consistent with and not contrary to approved labeling. No comparative promotional claim or claim of superiority over other products should be made unless data to support such claims are submitted to and approved by the Center for Biologics Evaluation and Research.
This information will be included in your biologic license application file.
--- signature ---
Karen D. Weiss, M.D.
Division of Clinical Trial Design and Analysis
Office of Therapeutics Research and Review
Center for Biologics Evaluation and Research
Last Updated: 1/16/2001
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Date created: September 25, 2003