FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

EU Grants Shire Conditional Marketing Authorization for Natpar

May 2, 2017
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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.

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