Tuesday, December 10, 2013
Please comment FDA decision for Pirfenidone. For how long availability for treatment will be delayed? Are there any other options? Thanks.
The FDA asked the manufacturer of pirfenidone (Intermune Pharmaceutical Company) to provide additional clinical trial data before they would approve the drug for general use. Intermune has indicated that they will be having direct discussions with the FDA in 2-3 months to determine what type of data is required and whether they will need to do an additional clinical trial. This will likely mean that pirfenidone will not be available for at least a couple of years, if it is ever approved.
Pirfenidone is currently available in
. There are several clinical trials underway at some of the academic medical centers throughout the country. If you are interested in clinical trial of new and experimental medications, then you should check with the closest academic medical center to where you live. Japan
James N Allen, Jr, MD
Clinical Professor of Pulmonary, Allergy, Critical Care & Sleep Medicine
College of Medicine
The Ohio State University