Novartis’ blood disorder drug gets FDA approval for expanded use

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).

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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.

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