FDA Approves Adakveo to Reduce Vaso-Occlusive Crises in Patients with Sickle-Cell Disease

On November 15, 2019, the FDA approved crizanlizumab (Adakveo; Novartis) to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients aged ≥16 years with sickle-cell disease.

The FDA approval of crizan­lizumab was based on data from the randomized, double-blind SUSTAIN clinical trial of 198 patients with sickle-cell disease who have had 2 to 10 VOC episodes in the 12 months before study enrollment. The primary efficacy end point in the trial was the annual rate of VOCs leading to a healthcare visit.

Patients were randomized to receive crizanlizumab 5 mg/kg (N = 67), criz­anlizumab 2.5 mg/kg (N = 66), or placebo (N = 65) administered intravenously in week 0, week 2, and every 4 weeks thereafter. Total treatment duration was 52 weeks.

Results showed that treatment with crizanlizumab significantly lowered the median annual rate of VOCs compared with placebo (1.63 vs 2.98; P = .01). Median time to first VOC from randomization was 4.1 months with crizanlizumab and 1.4 months with placebo.

The most common (>10%) adverse reactions in patients receiving crizanlizumab were nausea, arthralgia, back pain, and pyrexia.

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