Novartis sickle-cell drug gets U.S. FDA approval

Credit: REUTERS/ARND WIEGMANN

By John Miller and Carl O'Donnell

Nov 15 (Reuters) - Novartis NOVN.S on Friday won U.S. approval for its experimental sickle cell disease drug, making it the first of several proposed new therapies designed to offer lasting relief for patients with the debilitating blood disease to get U.S. regulatory clearance.

The biologic drug, also known as crizanlizumab, was shown in trials in its high-dose formula to cut sickle cell pain crises nearly by half to 1.63 incidents annually from 2.98 in those getting a placebo.

Novartis has forecast that the drug's annual sales will top $1 billion, much of which will likely come from U.S. government payers such as Medicare and Medicaid.

(Reporting by John Miller in Zurich, Carl O'Donnell in New York and Trisha Roy in Bengaluru; Editing by Arun Koyyur)

((J.Miller@thomsonreuters.com; +41 58 306 7734; Reuters Messaging: j.miller.thomsonreuters.com@reuters.net))

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