InterMune seeks FDA marketing approval for pirfenidone

InterMune, Inc. (Nasdaq: ITMN) today announced that it has submitted an electronic New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF). Pirfenidone has been granted Orphan Drug and Fast Track designation by the FDA, and also has been granted Orphan Drug status in Europe.

"IPF is a rapidly and uniformly fatal disease. Sadly, there are no medicines approved for the approximately 100,000 Americans who suffer from this terrible disease," said Dan Welch, Chairman, Chief Executive Officer and President of InterMune. "InterMune has dedicated almost ten years to the development of new medicines for patients with IPF. We are very proud to have submitted the first NDA ever submitted to the FDA for a medicine to treat IPF patients."

Source:

InterMune, Inc.

Comments

  1. Sandie Sandie United States says:

    Be aware the quality of life may be greatly affected by the photo-sensitivity you will have while taking this medication.  Any exposure to sun causes a painful - uncomfortable skin like condition similar to a sunburn.  You will have to be entirely covered - including extremeties while outside.

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