Global Blood's (GBT) NDA & sNDA for Oxbryta Get Priority Review
Global Blood Therapeutics, Inc. GBT announced that the FDA has accepted the supplemental new drug application (“sNDA”) as well as a new drug application (“NDA”) for its only marketed drug, Oxbryta (voxelotor). The sNDA is seeking approval of Oxbryta for the treatment of sickle cell disease (“SCD”) in children aged four to 11 years, while the NDA is seeking approval for a new age-appropriate dispersible tablet dosage form of Oxbryta (300 mg) in pediatric patients.
With the FDA granting priority reviews to both the sNDA and the NDA, a decision from the regulatory body is expected on Dec 25, 2021. The priority reviews are likely to reduce the anticipated timeline for review of Oxbryta from 10 months to six months.
Oxbryta is currently approved by the FDA as an oral, once-daily treatment for SCD in patients aged 12 years or above.
Per the company, an estimated 17,000 children between four to 11 years have SCD in the United States with few treatments available currently. Hence, upon potential approval, Oxbryta can serve an area of high unmet medical need for the SCD community.
Shares of Global Blood have plunged 31.2% so far this year against the industry’s increase of 2.8%.
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Both the sNDA and the NDA for Oxbryta were based on data from the phase IIa HOPE-KIDS 1 study. Data from the same shows that weight-based treatment with the Oxbryta dispersible tablets leads to a rapid and sustained improvement in hemoglobin levels in children with SCD aged four to 11 years. Concurrent reduction of hemolysis or red blood cell destruction was also demonstrated in the study.
In July 2021, Global Blood submitted an sNDA to the FDA seeking accelerated approval of Oxbryta for the treatment of SCD in children aged four to 11 years. The company also submitted a separate NDA to seek approval for a pediatric weight-based formulation of Oxbryta.
In the first six months of 2021, Oxbryta generated sales worth $86.6 million, reflecting an increase of almost 90% year over year. A potential label expansion of the drug should drive sales in the future quarters.
Oxbryta is also under review in the EU for treating hemolytic anemia in patients with SCD who are 12 years of age and older.
Zacks Rank & Stocks to Consider
Global Blood currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Spero Therapeutics, Inc. SPRO, Vertex Pharmaceuticals Incorporated VRTX and Corvus Pharmaceuticals, Inc. CRVS, all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Spero Therapeutics’ loss per share estimates have narrowed 8.2% for 2021 and 10.6% for 2022, over the past 60 days.
Vertex’s earnings estimates have been revised 10.4% upward for 2021 and 7.2% upward for 2022 over the past 60 days.
Corvus Pharmaceuticals’ loss per share estimates have narrowed 24.4% for 2021 and 21.4% for 2022, over the past 60 days.
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