FDA grants priority review to Roche ’s Esbriet (pirfenidone) for unclassifiable interstitial lung disease

Basel, 21 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has accepted the company ’s supplemental New Drug Application (sNDA) and granted Priority Review for Esbriet® (pirfenidone) for the treatment of unclassifiable interstitial lung disease (UILD). The FDA is expected to make a decision on approval by May 2021.“Since its US approval, Esbriet has become a standard of care for people living with idiopathic pulmonary fibrosis. However, significant unmet need remains in fibrotic lung diseases, including unclassifiable interstitial lung disease (UILD),” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medi cal Officer and Head of Global Product Development. “We are working closely with the FDA in hopes of offering Esbriet to people with UILD, a rare and debilitating disease.” The sNDA is based on results from a pivotal, 24-week Phase II trial, which was the first randomised controlled study specifically designed and conducted solely in people with UILD.[1] The data were presented as a late-breaking abstract at the 2019 European Respiratory Society ’s annual meeting and simultaneously published inThe Lancet Respiratory Medicine.[2]In 2020, the FDA granted Orphan Drug Designation and Breakthrough Therapy Designation to Esbriet for UILD.About Unclassifiable Interstitial Lung DiseaseInterstitial lung disease (ILD) broadly describes a diverse group of more than 200 types of rare pulmonary diseases. ILDs sh...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news