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Find Clinical Drug Pipeline Developments & Deals for Voxelotor
Acquisition brings leading sickle cell disease portfolio and pipeline including Oxbryta® (voxelotor), a first-in-class medicine that directly targets the root cause of SCD, to Pfizer with potential to address critical needs in an underserved patient community.
Proposed acquisition drives growth by bringing leading sickle cell disease expertise and rare hematology portfolio and pipeline of GBT including Oxbryta (voxelotor) tablets for treatment of sickle cell disease (SCD) and GBT601.
Oxbryta (Voxelotor) works by increasing hemoglobin’s affinity for oxygen, inhibits sickle hemoglobin polymerization and resultant sickling and destruction of red blood cells leading to hemolysis and anemia, are primary pathologies faced by every single person living with SCD.
Oxbryta (voxelotor) is an oral, once-daily therapy for patients with sickle cell disease (SCD). Oxbryta works by increasing hemoglobin’s affinity for oxygen.
The first sickle hemoglobin polymerization inhibitor approved in Europe, Oxbryta increases hemoglobin levels and reduces sickling and hemolysis – the cause of long-term complications of sickle cell disease.
This positive opinion means that those patients living with SCD and meeting the eligibility criteria can gain early, pre-license access to voxelotor, while the MHRA completes its review of the Marketing Authorisation Application (MAA).
The FDA’s approval of the sNDA is based on data from the open-label Phase 2a HOPE-KIDS 1 Study, which showed that weight-based treatment with the dispersible tablet formulation of Oxbryta (Voxelotor) resulted in rapid and sustained improvements in hemoglobin.
CHMP opinion is based on Phase 3 HOPE study which demonstrated clinically meaningful and statistically significant improvements in Hb levels and reductions in hemolysis, for patients treated with Oxbryta (Voxelotor) as monotherapy or in combination with hydroxycarbamide.
GBT intends to use the remainder of the net proceeds from the offering for the continued commercialization of Oxbryta® (voxelotor) and the clinical development of Oxbryta® and GBT’s product candidates.
An oral, once-daily therapy, Oxbryta directly inhibits hemoglobin polymerization, the root cause of the sickling and destruction of red blood cells in SCD. The sickling process causes hemolytic anemia, which impairs oxygen delivery to the tissues and organs in the body.
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