Novartis receives EU approval for blood disorder treatment in children
Novartis (NYSE: NVS) has announced that Revolade (eltrombopag) has been approved in the EU for use in paediatric patients aged 1 and over for the treatment chronic blood disorder ITP (immune thrombocytopenic purpura).
This rare disease affects around five in 100,000 children each year, and is characterised by bruising easily and uncontrollable bleeding due to a low platelet count. As many as 36% of children with ITP experience it as a chronic condition.
Revolade stimulates and differentiates large cells found especially in the bone marrow, called magekaryocytes, from bone marrow stem cells to increase platelet production. The drug was originally produced by GSK, and was acquired by Novartis as part of its $16 billion purchase of GSK’s oncology portfolio last year, as part of an asset-swap agreement.
This approval was based on the positive results from the PETIT and PETIT2 clinical trials demonstrated meaningful clinical benefit with the safety profile of Revolade consistent with other trials.
Alessandro Riva, global head of oncology and medical affairs at Novartis, says: “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 drug has now been approved in all 28 EU member states, plus Iceland, Norway and Liechtenstein, for children with chronic ITP who are refractory to other treatments. This approval also includes the use of a new oral suspension formulation of the drug which is designed for younger children who may not be able to swallow tablets.
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