Pulmonary Fibrosis Foundation President, Daniel M. Rose M.D., responds to the PF Community in regards to the FDA's rejection of pirfenidone
We realize many in the IPF community are disappointed at the FDA for not approving pirfenidone. It is somewhat unusual for the FDA to deny approval when the Advisory Board recommends approval (as it did in this case 9-3). It seems that the FDA may have been concerned that one of the trials did not demonstrate statistically significant benefit and therefore requested further studies be performed. Intermune, the manufacturer of pirfenidone, has scheduled a meeting with the FDA in the near future (view the press release here - http://www.prnewswire.com/news-releases/intermune-receives-fda-complete-...), and we should find out what further studies and information will be required.
Nevertheless, we feel that it is critically important the FDA hear the opinions of the patients, families, and caregivers. If you would like to comment, you can contact the FDA through this address (you can fax or mail a letter):
Badrul Chowdhury, M.D., Ph.D.
Division of Pulmonary, Allergy, and Rheumatology Products (HFD - 570)
Office of Drug Evaluation II
Center for Drug Evaluation and Research
Food and Drug Administration
5901 - B Ammendale Road
Beltsville, MD 20705-1266
Offices: (301) 496-9167
Pulm Division General Number: (301)796-1220
Dept FAX number: (301) 796-9728
We would hope that this matter is clarified in an expeditious and fair manner.
Dan Rose, MD