FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

EU Grants Shire Conditional Marketing Authorization for Natpar

May 2, 2017

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.

View today's stories