Novartis’s Revolade approved in Europe for children with chronic ITP

Novartis has announced that its drug Revolade has been approved by the European Commission for the treatment of chronic immune or idiopathic thrombocytopenic purpura (ITP).

The approval clears the drug for use as a treatment for paediatric patients aged one year and above who are refractory to other therapies. It includes the use of tablets, as well as a new oral suspension formulation of Revolade designed specifically for children.

Data from pivotal clinical trials has shown that treatment with Revolade significantly increased and sustained platelet counts among paediatric patients with chronic ITP who were refractory to or had relapsed after prior treatment.

Moreover, some of the patients taking concomitant ITP medications were able to reduce or discontinue their use of these other therapies, primarily corticosteroids.

Dr Alessandro Riva, global head of development and medical affairs at Novartis Oncology, said: "For the families and caregivers of children affected by a rare disease, having a new treatment option can be game-changing in managing the disease."

ITP is a rare blood disorder that affects about five in 100,000 children each year. Patients have a low number of platelets, meaning they bruise easily and have difficulty stopping bleeding.