Global Blood Therapeutics Gets FDA Approval for Supplemental NDA
September 07 2021 - 08:45AM
Dow Jones News
By Chris Wack
Global Blood Therapeutics Inc. said the U.S. Food and Drug
Administration has accepted for filing and review the company's
supplemental New Drug Application seeking accelerated approval for
Oxbryta voxelotor for the treatment of sickle cell disease in
children ages 4 to 11 years.
The company said the FDA also accepted its New Drug Application
seeking approval for a new age-appropriate dispersible tablet
dosage form of Oxbryta suitable for pediatric patients.
Oxbryta, a first-in-class therapy that directly targets
hemoglobin polymerization, the root cause of red blood cell
sickling in SCD, is currently approved by the FDA in a tablet
dosage form to treat SCD in patients age 12 years and older.
The FDA granted Priority Review for both the NDA and sNDA,
providing a six-month review, and assigned a Prescription Drug User
Fee Act target action date for both applications of Dec. 25.
The company said the NDA seeks approval for 300 mg dispersible
tablets. The dispersible tablet formulation includes grape
flavoring, is intended to be dispersed in room-temperature drinking
water or other clear drinks for ease of swallowing, and allows for
weight-based dosing in pediatric patients ages 4 to 11 years with
SCD.
Global Blood shares were up 3%, to $30.98, in premarket
trading.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
September 07, 2021 08:30 ET (12:30 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
Global Blood Therapeutics (NASDAQ:GBT)
Historical Stock Chart
From Feb 2024 to Mar 2024
Global Blood Therapeutics (NASDAQ:GBT)
Historical Stock Chart
From Mar 2023 to Mar 2024