Four new drugs backed for approval, including one orphan, by EMA/CHMP

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended four new medicines for approval at its February meeting.

The CHMP recommended granting a conditional marketing authorization for Ireland-headquartered Shire’s (LSE: SHP) Natpara (parathyroid hormone) as a treatment for patients with chronic hypoparathyroidism who cannot be adequately controlled with standard treatment with calcium and vitamin D. Natpara has an orphan designation.

To gain full approval, Shire will have to conduct a 26-week clinical trial to confirm the dosing schedule and further assess Natpara's safety and effect on symptoms and quality of life. Shire expects a final decision from the European Commission later this year.