Policy & Regulation
US FDA grants Global Blood Therapeutics' Oxbryta tablets accelerated approval
28 November 2019 -

The United States Food and Drug Administration (FDA) has granted United States-based Global Blood Therapeutics (GBT) Inc accelerated approval for Oxbryta (voxelotor) tablets intended for the treatment of sickle cell disease (SCD) in adults and children 12 years of age and older, it was reported yesterday.

The product is an oral therapy taken once daily and is the first approved treatment that directly inhibits sickle haemoglobin polymerisation, the root cause of SCD. It is likely to be offered through GBT's specialty pharmacy partner network within two weeks.

The accelerated approval of the product is reportedly based on clinically meaningful and statistically significant improvements in haemoglobin levels, accompanied by decrease in red blood cell destruction (hemolysis). Data from the Phase three HOPE (Hemoglobin Oxygen Affinity Modulation to Inhibit HbS PolymErisation) Study of 274 patients 12 years of age and older with SCD indicated that, after 24 weeks of treatment, 51.1% of patients receiving Oxbryta achieved a greater than 1g/dL increase in haemoglobin compared with 6.5% receiving placebo (p

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