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news.InterMune has announced that its program for the development of pirfenidone for the treatment of idiopathic pulmonary fibrosis has received fast track designation from the FDA.
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Fast Track is a designation that the FDA reserves for a drug intended to treat a serious or life threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. The FDA takes appropriate actions to facilitate the development and expedite the review of the approval applications for fast track products.
Dan Welch, chairman and CEO of InterMune, said: “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 idiopathic pulmonary fibrosis, in January of 2009.”