EU Grants Shire Conditional Marketing Authorization for Natpar
Swiss drug manufacturer, Shire, has acquired conditional marketing approval for Natpar from the European Commission.
The drug was developed as a hormone therapy indicated as an adjunctive treatment for adult patients with chronic hypoparathyroidism which is not adequately controlled with standard therapy.
The authorization was based on a Phase 3 efficacy and safety clinical trial in patients aged 19-74 years with chronic hypoparathyroidism, in which Natpar maintained serum calcium while reducing oral calcium and active vitamin D supplemental doses.
The product is approved in the U.S. under the trade name Natpara.