logo
Plus   Neg
Share
Email

FDA Grants Priority Review To Genentech' Esbriet For Unclassifiable Interstitial Lung Disease

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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Chico's FAS Inc. (CHS) Tuesday reported a wider year-over-year net loss for the fourth quarter. Meanwhile, Kohl's Corp.'s (KSS) fourth-quarter net income grew 29 percent from the previous year. But Abercrombie & Fitch Co.'s (ANF) fourth-quarter net income decreased 1 percent from the prior year. The U.S. Food and Drug Administration has approved the marketing of a new robotically-assisted surgical device (RASD) that can facilitate transvaginal hysterectomy in certain patients using minimally-invasive surgical instruments. The Hominis Surgical System of Memic Innovative Surgery Ltd., the U.S. subsidiary of Israeli biotechnology company memic Ltd., has been granted marketing authorization. Canadian cannabis company Canopy Growth Corp. (CGC, WEED.TO) announced Tuesday the launch of its Cannabidiol (CBD) beverage brand Quatreau in the high-potential U.S. market. Quatreau will be sold on Canopy's one-stop U.S. e-commerce destination, www.shopcanopy.com. Quatreau is a premium ready-to-drink...
Follow RTT