FDA Approves Novel Sickle Cell Disease Treatment

December 3, 2019

FDA Approves Novel Sickle Cell Disease Treatment

The FDA granted accelerated approval to Oxbryta (voxelotor), a novel inhibitor of deoxygenated sickle hemoglobin polymerization, the central abnormality in patients with sickle cell disease.The Accelerated Approval pathway enables the FDA to approve drugs for serious conditions based on results showing it is likely to provide clinical benefits to patients. Yourway has extensive experience expediting clinical trials to take advantage of fast-tracked approval pathways.

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