Amgen’s Nplate recommended for EU approval in paediatric indication

Amgen has announced that its thrombocytopenic purpura therapy Nplate has been recommended for EU approval in a new paediatric indication.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has backed the expansion of the current indication for Nplate to include the treatment of chronic immune thrombocytopenic purpura (ITP) for patients one year of age and older who are refractory to other treatments.

This decision was based on five studies evaluating the safety and efficacy of Nplate in children with ITP, including four completed trials and one ongoing long-term safety and efficacy study.

ITP is a rare, serious autoimmune disease characterised by low platelet counts and impaired platelet production. Around four or five cases are diagnosed per 100,000 children each year in Europe.

Dr Sean Harper, executive vice-president of research and development at Amgen, said: "We are pleased by today's positive CHMP opinion and look forward to working with European regulatory authorities to deliver on our commitment to bring Nplate to paediatric patients."

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