FDA Grants Priority Review to Esbriet for Unclassifiable Interstitial Lung Disease

FDA Grants Priority Review to Esbriet for Unclassifiable Interstitial Lung Disease

286166

FDA Grants Priority Review to Esbriet for Unclassifiable Interstitial Lung Disease

The U.S. Food and Drug Administration (FDA) has accepted and granted priority review to an application for Esbriet (pirfenidone) as a treatment for unclassifiable interstitial lung disease (UILD). The supplemental new drug application was submitted by Genentech, Esbriet’s developer and a member of the Roche Group, based on positive results from a pivotal, 24-week Phase 2 trial (NCT03099187) in adults with UILD. A decision on the approval is expected from the FDA by May of…

You must be logged in to read/download the full post.