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Oxbryta (voxelotor)
$40,365.00
Oxbryta (voxelotor) is a hemoglobin S polymerization inhibitor indicated for the treatment of sickle cell disease in adults and children 12 years of age and older.
This medicine is not (yet) part of our standard product range but we may be able to get it for you. The packaging size and strength below may vary due to product availability. Please contact us to verify price and availability.
NOTE: This medicine can only be purchased on behalf of a hospital. Additional documents may be required. Please contact us for details.
The Food and Drug Administration granted accelerated approval to Oxbryta (voxelotor) based on increase in hemoglobin among participants of the HOPE study, a randomized, double-blind, placebo-controlled, multicenter trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).[1,2]
Efficacy of Oxbryta (voxelotor) was evaluated in 274 patients with sickle cell disease. Participants were randomly assigned to receive a once-daily oral dose of 1,500 mg of voxelotor (N=90), 900 mg of voxelotor (N=92), or placebo (N=92). Patients were enrolled if they had from 1 to 10 vasoocclusive crisis (VOC) events within 12 months prior to enrollment and their baseline hemoglobin (Hb) were ≥5.5 to ≤10.5 g/dL. Patients on stable hydroxyurea doses for at least 90 days continued the drug throughout the trial.[1,2]
The primary endpoint was the percentage of participants who had a hemoglobin response, which was defined as an increase from baseline of more than 1.0 g per deciliter after 24 weeks of treatment, in patients treated with 1,500 mg of voxelotor versus placebo who showed >1g/dL increase in blood hemoglobin levels:
- 51.1% (46/90) of the patients receiving 1,500 mg of voxelotor, and
- 6.5% (6/92) of the patients receiving a placebo.[1,2]
Tablets | 90 film-coated of 500 mg |
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