FDA Approves Novartis' Adakveo for Some Patients with Sickle Cell Complications
November 15 2019 - 4:14PM
Dow Jones News
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)
Copyright (c) 2019 Dow Jones & Company, Inc.
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