InterMune needs breath of fresh air after FDA rejection

Tuesday, April 15th, 2014 By

Bottle and pills

InterMune has been given a bitter pill to swallow. Image from Wikimedia Commons

The FDA has been having a busy week, after approving Provenge for use and taking Tylenol to task, it has given InterMune a cold shot. InterMune had previously submitted a drug 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 apparently 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.  However, the FDA did not see sufficient evidence of efficacy in a second clinical trial, and this announcement and subsequent rejection sent prices plummeting.  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.  After the word from the FDA, InterMune stock, designated ITMN, was sent plummeting to the bottom, losing 80 percent of its value or $36 per share.

Wonder drug to treat Pulmonary Fibrosis

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

Back to the drawing board

Some feel the FDA should have been more lenient, considering the vicious nature of the disease. This isn’t entirely bad news, as it means that InterMune will likely return to work on the drug. In turn, this may lead to a more effective treatment than pirfenidone, which had only undergone the second round of clinical trials. Even in the first, it did not reverse the disease or damage caused by it.

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