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.
