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 Product Approval Information

Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

February 10, 2000

Our Reference No.: 99-0975

Ms. Staci Ellis
InterMune Pharmaceuticals, Inc.
3294 West Bayshore Road
Palo Alto, CA 94303

Dear Ms. Ellis:

Your request to supplement your biologics license application for Interferon gamma-lb to include a new indication for delaying time to disease progression in patients with severe, malignant osteopetrosis has been approved.

We acknowledge your agreement to provide additional information and to conduct post-marketing studies as described in your commitment letter of February 9, 2000, and as outlined below:

  1. You will establish a registry for all patients with severe, malignant osteopetrosis who are treated with Interferon gamma-lb. The registry data will include information about disease progression (e.g., time to progression, progression-defining event) on all patients. For patients in the registry £ 3 years of age, you will collect the following laboratory data twice per year for three years of treatment: 1) WBCs to assess neutropenia, and 2) liver function tests. You will also collect information on the generation of neutralizing antibodies in all patients treated with Interferon gamma-lb. You will submit data collection forms to be utilized in the registry by June 15, 2000. The collected data will be submitted to the IND annually.
  2. You will follow the patients from the Phase III trial who are currently enrolled in a continuation protocol to determine the median time to disease progression, and to submit a supplement to update the package insert once the median is reached. Please describe the status of this study in your annual reports to the IND.
  3. You will assess approaches for studying the effect of ACTIMMUNE on the response of patients to normal childhood vaccinations, and submit a proposed plan of study by August 2000.
  4. You will submit by December 2000 a supplement to revise labeling regarding safety and efficacy of pediatric use in Chronic Granulomatous Disease patients less than 1 year of age. You will include updated safety data and analysis for patients less than 1 year of age and those less than 3 years of age.
  5. At, or prior to, the time the new labeling is implemented, you will send a "Dear Dr. Letter" to physicians who have prescribed ACTIMMUNE for Chronic Granulomatous Disease over the past two years to notify them of the changes regarding the expression of the units of activity of ACTIMMUNE. You will send this letter to an appropriate list of physicians, to be agreed upon with the Agency and will submit a draft of this letter for our review at least two weeks prior to issuance.

Please submit final printed labeling at the time of use and include implementation information on FDA Form 2567. Please provide a PDF-format electronic copy as well as original paper copies (ten for circulars and five for other labels). 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 an 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 biologics license application file.

Sincerely yours,
--- 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: 1/14/2001

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Date created: September 25, 2003

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