InterMune’s potential lung condition treatment gets priority review by FDA
By APMonday, January 4, 2010
InterMune drug gets FDA priority review
BRISBANE, Calif. — InterMune Inc. said Monday the Food and Drug Administration granted the biotechnology company’s developing lung condition drug pirfenidone priority review.
Pirfenidone is aimed at the chronic lung disease idiopathic pulmonary fibrosis, which affects about 200,000 people in the U.S. and Europe.
The special designation speeds up the regulatory review process to six months from the usual 10 months. The FDA is scheduled to make decision by May. 4.
The drug candidate was licensed from Marnac Inc. and its co-licensor, KDL GmbH, in 2002. In 2007, InterMune bought rights to sell the drug in the U.S., Europe and other territories except Japan, Taiwan and South Korea.
Shares of InterMune fell 4 cents to $13 in morning trading.
