CHMP gives positive opinion on update for Esbriet in IPF-Roche
Esbriet (pirfenidone), from Roche, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for an update to its European prescribing information, strengthening the efficacy claims and supporting the well-established safety profile based on the additional data from the phase III ASCEND trial. Approved in the EU in 2011, Esbriet is indicated for the treatment of adults with mild to moderate Idiopathic Pulmonary Fibrosis. Pooled analysis of ASCEND and two CAPACITY Phase III trials show 48 percent reduction in mortality risk at one year. ASCEND data reinforces the Esbriet safety and efficacy profile.
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