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FDA approves Global Blood Therapeutics's sickle cell disease drug

Credit: REUTERS/Jason Reed

The U.S. Food and Drug Administration said on Monday it had approved Global Blood Therapeutics's drug, Oxbryta, to treat sickle cell disease in adults and pediatric patients aged 12 years or older.

Adds details on the drug

Nov 25 (Reuters) - The U.S. Food and Drug Administration said on Monday it had approved Global Blood Therapeutics's GBT.O drug, Oxbryta, to treat sickle cell disease in adults and pediatric patients aged 12 years or older.

The disease is a lifelong, inherited blood disorder in which abnormally shaped red blood cells restrict flow of blood in vessels, leading to severe pain and organ damage.

The drug, also known as voxelotor, aims to treat the underlying cause of sickle cell disease by preventing sickle cells from deforming. Its approval comes three months ahead of the previously set target date by the agency.

The drug's approval comes more than a week after Novartis AG's NOVN.S sickle-cell disease drug, Adakveo, received U.S. regulatory clearance.

"Today's approval provides additional hope to the 100,000 people in the U.S., and the more than 20 million globally, who live with this debilitating blood disorder," the FDA said.

The company's shares were up about 7% before being halted, pending the news.

(Reporting by Trisha Roy in Bengaluru; Editing by Anil D'Silva)

((Trisha.Roy@thomsonreuters.com; within U.S. +1 646 223 8780, outside U.S. +91 80 6749 7786;))

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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