InterMune, Inc.'s pirfenidone for the treatment of idiopathic pulmonary fibrosis (IPF) has received "Fast Track" designation from the FDA. Fast Track designation is granted for drugs intended to treat a serious or life threatening condition that have the potential to address an unmet medical need. The FDA facilitates the development and expedites the review of applications for fast track products.
Dan Welch, chairman and chief executive officer of InterMune, said, "There are no approved medicines to treat patients who suffer from IPF, a uniformly fatal disease characterized by scarring and inflammation of the lungs. The FDA's action in granting fast track designation is an indication of pirfenidone's potential to address this serious, unmet medical need. We look forward to reporting top-line results of our Phase III CAPACITY program of pirfenidone in IPF, in January of 2009."
InterMune's Pirfenidone Gets Fast Track Designation
Published May 19, 2008
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