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April 10, 2016

EC approves Novartis’ Revolade to treat chronic ITP in children

Novartis has received approval from the European Commission (EC) for its Revolade (eltrombopag) for children aged one year and above with chronic immune (idiopathic) thrombocytopenic purpura (ITP).

Novartis

Novartis has received approval from the European Commission (EC) for its Revolade (eltrombopag) for children aged one year and above with chronic immune (idiopathic) thrombocytopenic purpura (ITP).

ITP is a blood disorder characterised by blood that does not clot as it should due to a low number of platelets.

In most cases, an autoimmune response is thought to cause ITP, in which a person’s immune system attacks and destroys its own platelets.

Chronic ITP, defined as ongoing disease more than 12 months after diagnosis, occurs in 13-36% of children with ITP.

Revolade has been approved as first-in-class therapy for ITP patients who are refractory to other treatments such as corticosteroids, immunoglobulins.

It can either be administered as tablets or as an oral suspension formulation, which is designed for younger children who may not be able to swallow tablets.

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Revolade was approved by the EC in 2010 for use in adults with the same condition.

"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."

This once-daily oral thrombopoietin (TPO) receptor agonist works by inducing stimulation and differentiation of megakaryocytes (large cells, found especially in bone marrow) from bone marrow stem cells to increase platelet production.

Novartis oncology development and medical affairs global head Alessandro Riva 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."

The approval is based on two double-blind, randomised, placebo-controlled trials, in which efficacy, safety and tolerability of Revolade was evaluated in paediatric patients aged between one and 17 years with previously treated chronic ITP.

In September last year, the EC approved Revolade for the treatment of adults with severe aplastic anaemia who were either refractory to prior immunosuppressive therapy or heavily pre-treated, and are unsuitable for haematopoietic stem cell transplant.


Image: Novartis headquarters in Basel. Photo: courtesy of Andrew.

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