Ade Dotun's Blog – November 2019 Archive (1)

FDA approves voxelotor for sickle cell disease

On November 25, 2019, the Food and Drug Administration granted accelerated approval to voxelotor (Oxbryta, Global Blood Therapeutics) for adults and pediatric patients 12 years of age and older with sickle cell disease.

The primary efficacy outcome measure was Hb response rate defined as an Hb increase of >1 g/dL from baseline to week 24. The response rate for voxelotor was 51.1% (46/90) compared to 6.5% (6/92) in the placebo group (p<0.0001). Additional efficacy…

Continue

Added by Ade Dotun on November 27, 2019 at 7:01pm — No Comments

© 2024   Created by Ade Dotun.   Powered by

Badges  |  Report an Issue  |  Privacy Policy  |  Terms of Service