Adakveo Approval History
Reviewed by J.Stewart BPharm. Last updated on Nov 20, 2019.
FDA Approved: Yes (First approved November 15, 2019)
Brand name: Adakveo
Generic name: crizanlizumab-tmca
Dosage form: Injection
Company: Novartis Pharmaceuticals Corporation
Treatment for: Prevention of Vaso-Occlusive Crises (VOCs) in Sickle Cell Disease
Adakveo (crizanlizumab-tmca) is a P-selectin inhibitor for the prevention of vaso-occlusive crises (VOCs) in patients with sickle cell disease (SCD).
- Vaso-occlusive crises occur when the microcirculation is obstructed by sickled red blood cells. Adakveo works by binding to P-selectin, a cell adhesion protein that plays a central role in the multicellular interactions that can lead to vaso-occlusion.
- FDA approval of Adakveo was based on the results of the SUSTAIN trial, a 52-week, randomized, placebo-controlled, double-blind study of 198 patients with sickle cell disease and a history of VOCs. Adakveo reduced the annual rate of sickle cell pain crises by 45% compared to placebo (1.63 vs 2.98) and the annual rate of days hospitalized by 42% (4 vs 6.87).
- Adakveo is administered via intravenous infusion over a period of 30 minutes on Week 0, Week 2, and every 4 weeks thereafter.
- Patients receiving Adakveo should be monitored for signs and symptoms of infusion-related reactions. Adakveo may also cause interference with laboratory tests used to measure platelet counts.
- Common adverse reactions include nausea, arthralgia (joint pain), back pain, and pyrexia (fever).
Development History and FDA Approval Process for Adakveo
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