Novartis’ Revolade recognised as breakthrough therapy for SAA

Novartis has announced that its drug Revolade has been recognised as a potential breakthrough treatment for a rare and serious form of anaemia.

The US Food and Drug Administration has granted breakthrough therapy designation to the drug for use in combination with standard immunosuppressive therapy for the treatment of patients with severe aplastic anaemia (SAA) as a first-line therapy.

The medicine – which is known as Promacta in the US – has been shown to deliver complete responses among 52 percent of patients with treatment-naive SAA at six months, when delivered concurrently with standard immunosuppressive treatment.

Breakthrough therapy designation is given to drugs those that demonstrate a substantial improvement over existing therapies for serious or life-threatening diseases and conditions.

Dr Samit Hirawat, head of global drug development at Novartis Oncology, said: "Promacta is a promising medicine that, if approved for first-line use in severe aplastic anaemia, may redefine the standard of care for patients with this rare and serious bone marrow condition."

The drug has already been approved as a second-line therapy in the refractory setting in SAA, and is also approved for adults and children with chronic immune thrombocytopenia.

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