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Amgen’s Mimpara recommended for EU paediatric approval
Amgen has announced that its oral calcimimetic agent Mimpara 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 adopted a positive opinion recommending approval of a paediatric formulation of Mimpara for the treatment of secondary hyperparathyroidism in children aged three years and older with end?stage renal disease on maintenance dialysis therapy.
Mimpara will help to deliver relief for children whose condition has not been adequately controlled with standard of care therapy, as this group currently has few available treatment options.
The CHMP recommendation was based on studies Amgen began in 2007, which have shown the safety and efficacy of the drug in this indication.
Dr Sean Harper, executive vice-president of research and development at Amgen, said: "We are pleased by today's positive CHMP opinion, as Mimpara could provide an important therapeutic option for paediatric patients living with secondary hyperparathyroidism."
Mimpara was originally approved in the EU in 2004 and was the first oral calcimimetic agent to be made available for the treatment of this condition in Europe.
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