Genentech, a member of the Roche Group (RHHBY), said Thursday that the U.S. Food and Drug Administration has accepted the company's supplemental New Drug Application or sNDA and granted Priority Review for Esbriet or pirfenidone for the treatment of unclassifiable interstitial lung disease or UILD.
It is expected that the FDA will take a decision on approval by May 2021.
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.
In 2020, the FDA granted Orphan Drug Designation and Breakthrough Therapy Designation to Esbriet for UILD.
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