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  • FDA grants priority review to Genentech’s Esbriet ...

FDA grants priority review to Genentech’s Esbriet for unclassifiable interstitial lung disease.

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Published:22nd Jan 2021
Genentech, a member of the Roche Group announced that the 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 U.S. 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., chief medical 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 randomized controlled study specifically designed and conducted solely in people with UILD. The data were presented as a late-breaking abstract at the 2019 European Respiratory Society’s annual meeting and simultaneously published in The Lancet Respiratory Medicine. In 2020, the FDA granted Orphan Drug Designation and Breakthrough Therapy Designation to Esbriet for UILD. See- Pirfenidone in patients with unclassifiable progressive fibrosing interstitial lung disease: a double-blind, randomised, placebo-controlled, phase II trial. Lancet Respir Med. 2020, 8:147 DOI:https:// .
Condition: Interstitial Lung Disease/ILD
Type: drug

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