SOUTH SAN FRANCISCO (dpa-AFX) - Genentech, a member of the Roche Group (RHHBY), said that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to Esbriet or pirfenidone for adults with unclassifiable interstitial lung disease or uILD.
The designation was based on results from a Phase II trial, which suggested Esbriet slowed disease progression in patients with uILD at 24 weeks.
ILD is a term that broadly describes a diverse group of more than 200 types of rare pulmonary diseases.
Breakthrough Therapy Designation is designed to accelerate the development and review of medicines intended to treat serious or life-threatening conditions with preliminary evidence that indicates they may demonstrate a substantial improvement over existing therapies.
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