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Oxbryta FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (First approved November 25, 2019)
Brand name: Oxbryta
Generic name: voxelotor
Dosage form: Tablets
Company: Global Blood Therapeutics, Inc.
Treatment for: Sickle Cell Disease

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

Development timeline for Oxbryta

Dec 17, 2021Approval U.S. FDA Approves Supplemental New Drug Application for Expanded Indication of Oxbryta (voxelotor) for Children as Young as 4 Years of Age with Sickle Cell Disease
Nov 25, 2019Approval FDA Approves Oxbryta (voxelotor) for the Treatment of Sickle Cell Disease
Oct 21, 2019GBT Announces Results of Post-hoc Analysis of Phase 3 HOPE Study Showing Improvement in Leg Ulcers in Patients with Sickle Cell Disease Treated with Voxelotor
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, 2018GBT 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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