Novartis' blood disorder drug gets FDA approval for expanded use

FILE PHOTO: A Novartis logo is pictured on its headquarters building in Mumbai April 1, 2013. REUTERS/Vivek Prakash/File Photo

(Reuters) – Novartis AG said on Friday the U.S. Food and Drug Administration expanded the use of its low platelets drug to treat patients with a rare, genetic blood disorder.

The drug, Promacta, received the green light as a combination with standard immunosuppressive therapy to treat patients two years and older suffering from treatment-resistant severe aplastic anemia (SAA).

SAA is a blood disorder in which a patient’s bone marrow fails to produce enough red blood cells, white blood cells and platelets.

“Severe aplastic anemia can be a fatal diagnosis if left untreated, and many patients fail to respond to current initial treatment options,” Liz Barrett, chief executive of Novartis Oncology said in a statement.

Promacta has been approved in more than 90 countries as a treatment for low platelet count in patients with chronic immune thrombocytopenic purpura.

The FDA also designated the drug as a breakthrough therapy for decreasing the risk of hemorrhage in patients with radiation sickness.

European regulators are expected to decide on the drug’s use in SAA in 2019, Novartis said.

Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Sriraj Kalluvila

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