ASCEND Data Put InterMune’s Pirfenidone On Top
This article was originally published in Pharmaceutical Approvals Monthly
Phase III trial of idiopathic pulmonary fibrosis drug puts company in strong position for FDA approval of first treatment for orphan disease and strong reimbursement in U.S. and abroad.
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In a day of three positive recommendations helped by discounts, Bristol’s Orencia for rheumatoid arthritis, Novartis’ Xolair for Asthma and InterMune’s Esbriet for IPF finally make it onto the U.K.’s NHS payroll.
In the latest in “The Pink Sheet”’s market snapshot series, InterMune continues to work on getting pirfenidone approved in the U.S., while several companies are developing next-stage therapies for IPF.
FDA requests an additional efficacy trial, not surprising given that the IPF drug met the primary endpoint in only one of two Phase III trials.