InterMune says FDA panel will review its lung drug
Drug developer InterMune Inc. said Friday it will meet with a Food and Drug Administration panel Tuesday to discuss its drug candidate pirfenidone, which is designed to treat a rare and chronic lung disease.
The FDA's Pulmonary-Allergy Drugs Advisory Committee will discuss results from clinical studies and make a recommendation to the FDA on whether pirfenidone should be approved as a treatment for idiopathic pulmonary fibrosis.
The FDA does not have to follow the advice of its panels, but if pirfenidone gets a positive recommendation for the panel, it is more likely to be approved.
In premarket trading, InterMune stock surged $6.94, or 47.5 percent, to $21.55. The stock last traded above $20 in September 2008.
Around 200,000 people in the U.S. and Europe have idiopathic pulmonary fibrosis, according to Intermune, and there are no drugs approved to treat the disease. InterMune wants to market the drug under the name Esbriet. The drug was approved in Japan in October 2008, where it is sold under the name Pirespa by Shionogi and Co.