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Voxelotor Approval Status

FDA Approved: No
Generic name: voxelotor
Company: Global Blood Therapeutics, Inc.
Treatment for: Anemia, Sickle Cell

Voxelotor is an oral, HbS (sickle hemoglobin) polymerization inhibitor in development for the treatment of patients with sickle cell disease (SCD).

Development Status and FDA Approval Process for voxelotor

DateArticle
Sep  5, 2019GBT Announces U.S. Food and Drug Administration Acceptance of New Drug Application and Priority Review for Voxelotor for the Treatment of Sickle Cell Disease
Jun 14, 2019GBT Announces Updated 24-Week Efficacy Data from All Patients Enrolled in Phase 3 HOPE Study Showing Statistically Significant and Sustained Improvements in Hemoglobin with Voxelotor
Dec  3, 2018 GBT Announces U.S. FDA Agrees with its Proposal Relating to Accelerated Approval Pathway for Voxelotor for the Treatment of Sickle Cell Disease and GBT Plans to Submit New Drug Application (NDA)

Further information

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