Novo Nordisk Submits Etavopivat to the Food and Drug Administration for Sickle Cell Disease: the Phase 3 Trial Cut Vaso Occlusive Crises by 27 Percent, for Patients Aged 12 and Older
Novo Nordisk announced on November 13 that it has submitted a New Drug Application to the U.S. Food and Drug Administration for the oral drug etavopivat, along with a marketing authorization application to the European Medicines Agency, for the treatment of sickle cell disease.
The applications cover patients aged 12 and older. A Food and Drug Administration decision is expected in 2027.
In the Phase 3 HIBISCUS trial, patients treated with etavopivat had 27 percent fewer vaso-occlusive crises than those on placebo, and the time to a first vaso-occlusive crisis was delayed by about four months compared with placebo.
At week 24 of the trial, 48.7 percent of patients in the treatment group achieved a hemoglobin response, compared with 7.2 percent on placebo.
The drug has previously received Fast Track, Rare Pediatric Disease and Orphan Drug designations from the Food and Drug Administration.
Source: Novo Nordisk
Published by GSM · USA (original Chinese edition)
Photo: 图：血红蛋白SC病（镰状细胞病的一种）患者血液涂片显微图像，可见靶形红细胞与镰状细胞。Spicy，CC BY-SA 4.0，经 Wikimedia Commons。 / Photo: Microscopic blood film in hemoglobin SC disease, a form of sickle cell disease, showing target and sickle cells. By Spicy, CC BY-SA 4.0, via Wikimedia Commons.
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