InterMune Receives FDA Breakthough Therapy Designation For Pirfenidone, An Investigational Treatment For IPF
BRISBANE, Calif., July 17, 2014 /PRNewswire/ — InterMune, Inc. (Nasdaq: ITMN) today announced that pirfenidone has been granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). This designation is reserved for drugs that are intended to treat a serious or life threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. As described in the FDA Fact Sheet: Breakthrough Therapies, “If a drug is designated as breakthrough therapy, FDA will expedite the development and review of such drug.” In May, InterMune resubmitted its New Drug Application (NDA) for pirfenidone and noted a target FDA review of six months under the Prescription Drug User Fee Act. Pirfenidone is an investigational treatment for adult patients with idiopathic pulmonary fibrosis (IPF).
“The Breakthrough Therapy Designation underscores the significant need to help patients with this irreversible and ultimately fatal disease, particularly as no FDA-approved therapies are currently available,” said Dan Welch, Chairman, Chief Executive Officer and President of InterMune. “We are pleased that the FDA recognized the importance of pirfenidone as a potential new therapy for IPF, a disease with great unmet medical need.”
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