Global Blood Therapeutics (GBT)

[Paullee]

Zacks Equity Research
Mon, December 20, 2021, 11:02 AM
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Global Blood Therapeutics, Inc. GBT announced that the FDA has granted accelerated approval to its supplemental new drug application (“sNDA”) for Oxbryta (voxelotor) to treat sickle cell disease (“SCD”) in children aged four to less than 12 years.

The regulatory body also approved the new drug application (“NDA”) for Oxbryta tablets for oral suspension – a new dispersible, once-daily tablet dosage for patients aged four to less than 12 years, as well as for older patients who have difficulty swallowing whole tablets.

Oxbryta is currently approved by the FDA as an oral, once-daily treatment for SCD in patients aged 12 years or above.

The FDA nod for the sNDA was based on data from the phase IIa HOPE-KIDS 1 study, which evaluated Oxbryta in the given patient population. Data from the same showed that weight-based treatment with the dispersible tablet formulation of Oxbryta led to rapid and sustained improvements in hemoglobin. Concurrent reduction of hemolysis or red blood cell destruction was also demonstrated in the study.

Shares of Global Blood have plunged 29.5% so far this year compared with industry’s decrease of 19%.