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Novartis: FDA expands use of severe aplastic anemia drug

(CercleFinance.com) - The US Food and Drug Administration has expanded the label for Novartis' Promacta to include first-line treatment of severe aplastic anemia in combination with standard immunosuppressive therapy, the Swiss drugmaker announced.


Promacta, which is marketed as Revolade in most countries outside the US, is already approved for severe aplastic anemia for patients who have had an insufficient response to immuno-suppressive therapy.

The FDA also granted Promacta breakthrough therapy designation as a counter measure for hematopoietic sub-syndrome of acute radiation syndrome, Novartis said.

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