Top-line data from a Phase III trial of InterMune’s lung drug pirfenidone has resurrected the candidate’s approval prospects after the FDA rejected the anti-fibrotic agent in 2010.
The ASCEND trial, which evaluated pirfenidone in patients with idiopathic pulmonary fibrosis, showed the drug significantly reduced disease progression and improved quality-of-life as measured by tests evaluating shortness of breath and walking distance, InterMune said Tuesday.
The drug was well tolerated and showed a favorable safety profile, the company added. There were more elevations in patients’ aminotransferase levels in the treatment arm compared to placebo, but the elevations generally occurred early and were manageable and reversible, InterMune said.
The company also lauded pirfenidone’s extensive postmarketing experience outside the U.S., which has yet to approve the drug for any indication. Pirfenidone is marketed as Esbriet in the EU and as Pirespa in Japan and South Korea.
InterMune’s NDA was previously the subject of an FDA complete response letter. The rejection letter followed concerns from agency advisors that more data would clarify the drug candidate’s safety and efficacy. The agency requested an additional trial for the idiopathic pulmonary fibrosis treatment.
InterMune is preparing to resubmit the NDA for pirfenidone later this year, President and CEO Dan Welch said. — Johnathan Rickman
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