Global Blood Gets FDA Approval of Supplemental New Drug Application for Oxbryta

By Michael Dabaie

Global Blood Therapeutics Inc. said the U.S. Food and Drug Administration granted accelerated approval of a supplemental new drug application for Oxbryta tablets for sickle cell disease in children ages 4 to less than 12.

Shares have been higher in Friday trading, and were recently up 8.8%, to $30.08.

The approval expands the previously approved use of Oxbryta to treat SCD in patients ages 12 years and older in the U.S.

The FDA also approved Global Blood's separate application for Oxbryta tablets for oral suspension. This is a new once-daily tablet dosage form suitable for patients 4 to less than 12 years, as well as for older patients who have difficulty swallowing whole tablets.

Global Blood Therapeutics said earlier Friday that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending marketing authorization for Oxbryta tablets for hemolytic anemia due to sickle cell disease in adults and pediatric patients 12 years and older.

Based on the CHMP opinion, a decision by the European Commission, which authorizes marketing approval in the European Union, is expected in the first quarter of 2022, the company said.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

December 17, 2021 14:42 ET (19:42 GMT)

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