FDA Approves Novartis' Adakveo for Some Patients with Sickle Cell Complications

   By Stephen Nakrosis

The U.S. Food and Drug Administration said Friday it approved Adakveo, or crizanlizumab-tmca, to treat certain complications arising in patients with sickle cell disease.

The approval was granted to Novartis AG (NVS), and is the first FDA approval for a "targeted therapy to treat patients with painful complication of sickle cell disease," the agency said.

"Adakveo is the first targeted therapy approved for sickle cell disease, specifically inhibiting selectin, a substance that contributes to cells sticking together and leads to vaso-occlusive crisis," said Richard Pazdur, director of the FDA's Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research.

"The Adakveo approval was based on the results of a randomized clinical trial enrolling 198 patients with sickle cell disease with a history of vaso-occlusive crisis," the FDA said.

--Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

November 15, 2019 15:59 ET (20:59 GMT)

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