Pulmonary Fibrosis

Fast Track Designation For Pirfenidone

10/06/2008 02:21PM

Question:

Pirfenidone has received "Fast Track" designation from the U.S. Food and Drug Administration (FDA). What do you think? When it will be available for prescription? Thanks

Answer:

The "Fast Track" designation permits a drug to go through the FDA approval process in an expedited fashion after a drug is submitted for approval. The drug has not yet been submitted to the FDA for approval, however. The multicenter pirfenidone study is in the completion phases and the results of the study are not yet available. If the study shows that pirfenidone is effective, then application will be made to the FDA. Per information available on the InterMune Pharmaceutical Company's website, the CAPACITY study of pirfenidone versus placebo is a 72 week study that closed to enrollment in May, 2007. Based on this information, the study be completed 72 weeks (18 months) after May, 2007 which would calculate to be in November, 2008. The standard FDA target date for approval for a new drug is 10 months. The "Fast Track" status can allow a drug to have a priority designation that sets a shorter target date for approval at 6 months. See attached Weblink.

Related Resources:

FDA Fast Track

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Response by:

James N. Allen, Jr., MD
Professor - Clinical
Pulmonary, Allergy, Critical Care & Sleep Medicine
Department of Internal Medicine
College of Medicine
The Ohio State University