Mimpara by Amgen has been given a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
The CHMP recommended that the drug receive Marketing Authorization to treat end-stage renal disease (ESRD) in children 3 years and older on maintenance dialysis therapy, specifically those who have not done well with standard therapy.
"We are pleased by today's positive CHMP opinion, as Mimpara could provide an important therapeutic option for pediatric patients living with secondary hyperparathyroidism," Dr. Sean Harper, executive vice president of Research and Development at Amgen, said in a statement.
The European Commission will now review the CHMP positive opinion and decide whether to approve marketing authorization for the drug in the 28 countries that are members of the E.U.
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