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Global Blood Therapeutics, Inc. GBT announced plans to expand the label of Oxbryta (voxelotor) for the treatment of sickle cell disease (SCD) in children aged 4 to 11 years, following a Type B meeting with the FDA.
In November 2019, the FDA approved Oxbryta as an oral, once-daily treatment for SCD in patients aged 12 years or above. Following this, the drug became the first and only therapy that directly inhibits sickle hemoglobin polymerization, a major cause for SCD. SCD is a chronic, inherited blood disorder that affects hemoglobin levels.
Global Blood plans to submit a New Drug Application (NDA) for Oxbryta, which will include a new, age-appropriate formulation, for the treatment of SCD in children 4 to 11 years under the FDA’s accelerated approval pathway. The NDA will include clinical data from the ongoing phase IIa HOPE-KIDS 1 study.
Shares of Global Blood have declined 17.2% so far this year against the industry’s growth of 7.9%.
The company has another pipeline candidate, inclacumab, which is a novel fully human monoclonal antibody against P-selectin, in its portfolio. The drug is being developed as a treatment for vaso-occlusive crises (“VOC”) in patients with SCD. The company is developing inclacumab with drug giant Roche Holding AG RHHBY.
Last year, the FDA also approved Novartis’ NVS Adakveo (crizanlizumab) to lower the frequency of VOCs or pain crises in patients with SCD, aged 16 years or above. bluebird bio BLUE is also developing LentiGlobin for the treatment of VOC in patients with SCD.
Global Blood Therapeutics, Inc. Price
Global Blood Therapeutics, Inc. price | Global Blood Therapeutics, Inc. Quote
Global Blood currently has a Zacks Rank #2 (Buy).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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