The FDA on Monday approved a Global Blood Therapeutics treatment for sickle cell disease, three months before the agency’s decision was expected.
Regulators evaluated the drug, voxelotor (Oxbryta), under a pathway that allows for a speedier review using less evidence than is typically required. This pathway is reserved for drugs that address an unmet medical need. But South San Francisco-based Global Blood (NASDAQ: GBT) must conduct additional clinical trials to maintain the drug’s approval.
Sickle cell disease is an inherited disorder that causes hemoglobin, the oxygen-carrying red blood cells, to take the shape of a crescent, or sickle. These misshapen… Read more »
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