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FDA committee recommends approval for InterMune’s Esbriet

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BRISBANE, Calif. A Food and Drug Administration committee has recommended approval for an investigational drug for treating a rare and fatal lung disease.

The FDA’s Pulmonary-Allergy Drugs Advisory Committee voted 9-3 to recommend that the agency approve InterMune’s Esbriet (pirfenidone), InterMune announced Wednesday.

The drug is used to reduce decline in lung function in patients with idiopathic pulmonary fibrosis, a disease that affects around 200,000 people in the United States and Europe. If approved, it would be the first IPF medication for U.S. patients. Because of the disease’s rarity, the FDA granted Esbriet Orphan Drug, Fast Track and Priority Review designations, and the agency is expected to reach a final decision on May 4.

“We are pleased with the outcome of today’s advisory committee meeting,” InterMune president, chairman and CEO Dan Welch said in a statement. “We look forward to working closely with the FDA as a review of the Esbriet NDA continues.”

An FDA advisory committee’s recommendations are taken into consideration when the FDA decides whether or not to approve a drug, though they are not binding.

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