Pirfenidone

It didn’t happen. After such promise, the FDA did not approve the “miracle drug” for Pulmonary Fibrosis. Here is a note from the head of the Coalition for Pulmonary Fibrosis regarding this huge disappointment:

The CPF would like to inform you that the FDA decided to request further study of Pirfenidone and not approve the drug at this time.

The CPF understands the disappointment that will be experienced in the PF community as a result of this decision by the FDA, but we remain hopeful that the company that owns Pirfenidone, InterMune, will be able to present the FDA with additional information studies that may alter this decision in not-too-distant future. We encourage our members to remain optimistic, to continue to do the wonderful work you have done to generate Congressional support for H.R. 1079, and to stay informed via our website for any updates or changes to news about PF research.

Please see below for content of the CPF press release sent out earlier today.

Sincerely,

Mishka Michon, CPF Chief Executive Officer

Coalition for Pulmonary Fibrosis Responds to News of Further Review of Pirfenidone By FDA
Decision Marks Delay in Potential First Treatment for Deadly Disease

San Jose, Calif. – May 4, 2010 - The Coalition for Pulmonary Fibrosis (CPF), representing tens of thousands of patients, is responding to the news that the FDA chose to ask for further study of Pirfenidone, which will delay potential approval of the first drug in the treatment of Pulmonary Fibrosis (PF), a lethal lung disease that is irreversible, progressive and deadly in an average of three years. On March 9, 2010, an FDA Advisory Committee recommended approval of the drug by the FDA.

“This news is disappointing for the Pulmonary Fibrosis patient community,” said Mishka Michon, CEO of the CPF. “Although the drug is not seen as a cure, it offers the first-ever option for treatment and some hope for these dying patients. This is a setback for those patients who are anxious to gain access to this treatment now. We look forward to results of further review of the drug by the FDA. We are hopeful that more attention to the disease will come and much will be learned that will encourage even more companies to research PF. The need is profound and urgent.”