Regulators in the European Union are set to consider whether Mimpara, a drug from Amgen used to treat parathyroid disease, can be used in children as young as 3 who also suffer from kidney failure.
If the application to expand Mimpara’s use to children suffering from hyperparathyroidism is approved, the drug could then be prescribed across some 30 European and Scandinavian countries, an Amgen release said. Mimpara has been approved for adult patients in the EU since 2004.
Hyperparathyroidism is a frequent side effect of dialysis, affecting many of the 2 million people worldwide with kidney failure. The condition causes bone deterioration as a result of hampered kidney activity.
Sean Harper, Amgen’s executive vice president of research and development, hailed a decision by the Committee for Medicinal Products for Human Use (CHMP), an advisory arm of the European Medicines Agency, to recommend the expanded use of Mimpara to the EU regulators.
"We are pleased by today's positive CHMP opinion, as Mimpara could provide an important therapeutic option for pediatric patients living with secondary hyperparathyroidism," Harper said in the release.
CHMP took into account Amgen's studies of Mimpara going back to 2007 in recommending the drug for expanded use, the release said.