FDA Rejection Makes InterMune Need A Breath Of Fresh air

The FDA has been really busy this week, approving Provenge for use, taking Tylenol to task, and giving InterMune the cold shot. InterMune had previously submitted a drug that was to treat pulmonary fibrosis for approval, and the FDA has turned InterMune down. The drug, called pirfenidone, was denied by the Food and Drug Administration because evidently it had failed to live up to expectations in a second clinical trial. It sent InterMune stock plummeting, and investors may be sent scrambling for unsecured loans to get back to drawing board.

InterMune wonder drug deflated by FDA

The InterMune corporation had previously had soaring stock prices. Prices went plummeting as the FDA did not see enough evidence of efficacy in a second trial. For the last few months, the company stock had been on a high, and earlier this week had been trading at $45.44 a share, according the New York Times. InterMune stock lost 80 percent of its value of $36 per share, after word from the FDA.

Pulmonary Fibrosis treated with wonder drug

Pirfenidone, the drug in question, would have treated symptoms of pulmonary fibrosis, including idiopathic pulmonary fibrosis. Pulmonary fibrosis is a disease which causes scarring and hardening of lung tissue. (Idiopathic means there is no known cause.) The disease is often fatal, and sufferers usually live only a couple of years after diagnosis. The drug would have been sold under the trade name Esbriet. The Times article says that without slowing any of the symptoms, the drug only postpones death for a short period of time. Therefore, there would be dubious benefit.

Back to the drawing board

Many felt the FDA should have allowed the drug considering the vicious nature of this disease. This isn’t bad news since it means InterMune will return to work on the drug. This might lead to a a lot more effective treatment than pirfenidone might have been, which had only undergone the second round of clinical trials. Even within the first trial it didn’t reverse the disease or damage that was caused.

Sources for the article

New York Times

http://www.nytimes.com/2010/05/05/business/05lung.html?src=busln