Global Blood Therapeutics Earns Priority Review for Sickle Cell Drug
The FDA granted Global Blood Therapeutics a priority review for Voxelotor, an oral, once-daily therapy for treating sickle cell disease.
The designation was granted based on the results of a phase 3 clinical trial which studied the drug in patients ages 12 and older with sickle cell disease who enrolled from 60 institutions across 12 countries.
The FDA previously granted Voxelotor other designations for treating patients with sickle cell disease over the past two years, including, breakthrough therapy and orphan drug designations last year. The agency’s decision date for Voxelotor is Feb. 26, 2020.