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Friday, December 6, 2013
Pirfenidone Compassionate Use Program
Will Intermune make pirfenidone available on a compassionate use basis before it is approved by FDA?
Pirfenidone is currently under review by the FDA, and it is anticipated that the FDA will make a decision about whether or not to approve it by May. Intermune has had a compassionate use registry in the past that requires a patient to go through their regular physician; most physicians are required to get authorization by their hospital's IRB (institutional review board, also called human subjects committee). In most cases, the process to go through the company and then the IRB takes 3-4 months so for most patients, there is not an advantage to go through the compassionate use protocol.If you have additional questions, I recommend that you contact the Intermune Pharmaceutical Company directly.
James N Allen, Jr, MD
Clinical Professor of Pulmonary, Allergy, Critical Care & Sleep Medicine
College of Medicine
The Ohio State University