The US Food and Drug Administration (FDA) has given its clearance to supplemental new drug application (sNDA) for GlaxoSmithKline’s (GSK) Promacta (eltrombopag) to treat patients with severe aplastic anaemia (SAA).
SAA is a blood disorder that consists of one marrow failing to produce sufficient red blood cells, white blood cells and platelets.
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GSK oncology president Dr Paolo Paoletti said: "FDA approval of Promacta addresses a significant treatment need for this very rare but serious blood disorder in those who have failed current treatment options.
"Through collaboration with the National Institutes of Health, whose studies demonstrate the potential for Promacta to achieve a haematologic response in at least one lineage, red blood cells, platelets, or white blood cells, patients now have a treatment option where one didn’t previously exist."
The approval was based on results from an investigator-sponsored Phase II study (09-H-0154) carried by the National Heart, Lung and Blood Institute (NHLBI) at the National Institutes of Health (NIH).
The study showed a haematologic response in SAA patients treated with eltrombopag, who had an insufficient response to immunosuppressive therapy (IST).
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By GlobalDataEltrombopag has been assessed in 43 patients with SAA, who had an insufficient response to at least one prior IST and who had a platelet count =30 x 109/L, in the Phase II study.
Eltrombopag is sold under the brand name Promacta in the US, while Revolade in ex-US countries.
It can also be used to treat thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia (ITP), who had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
GSK received Breakthrough Therapy designation from FDA for Promacta in January, while Priority Review in April this year.
