The US Food and Drug Administration has expanded the scope of Novartis’ immune thrombocytopenia drug Promacta to treat children with the rare clotting disorder.
The regulator has green-lighted its use for paediatric patients with chronic ITP aged six years and older who have failed to respond to corticosteroids, immunoglobulins or splenectomy, following clearance for adults back in 2008.
ITP affects around five in 100,000 children each year, up to 30% of which diagnosed with chronic forms of the condition and thus are at constant risk of significant bleeding.
Promacta’s (eltrombopag; sold as Revolade in the US) paediatric approval is based on Phase III data showing its ability to significantly increase and sustain platelet counts, which in some cases meant that patients were able to reduce or discontinue their use of other medications, such as corticosteroids, Novartis said.
The drug, which the Swiss drugs giant took on through its recent mega-deal and asset swap with GlaxoSmithKline, is also approved in the US for thrombocytopenia and severe aplastic anaemia.