Genentech's Esbriet Gets FDA Priority Review in Unclassifiable Interstitial Lung Disease

By Colin Kellaher

Roche Holding AG's Genentech unit on Thursday said the U.S. Food and Drug Administration granted priority review to the expanded use of Esbriet for the treatment of unclassifiable interstitial lung disease.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period. Genentech said the agency is expected to make a decision on its application by May.

Interstitial lung disease describes a group of more than 200 types of rare pulmonary diseases, each having different causes, treatment approaches and outlooks, Genentech said, adding that roughly 10% of patients can't be given a definitive diagnosis and are categorized as having unclassifiable interstitial lung disease.

The FDA approved Esbriet in 2014 to treat the lung disease idiopathic pulmonary fibrosis.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

January 21, 2021 06:54 ET (11:54 GMT)

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