Shire granted EU conditional marketing authorisation for Natpar for the treatment of chronic hypoparathyroidism
Natpar is the first and only licensed recombinant human parathyroid hormone therapy for chronic hypoparathyroidism.
Shire has announced that the European Commission (EC) has granted Conditional Marketing Authorisation for Natpar (rhPTH[1-84]), the first recombinant human protein with the full length 84-amino acid sequence of endogenous parathyroid hormone (PTH). Natpar will be the first and only approved hormone therapy indicated as adjunctive treatment for adult patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone.
The conditional marketing authorisation is based on the outcomes from the Phase III efficacy and safety of rhPTH(1-84) clinical trial (REPLACE) in patients aged 19-74 years with chronic hypoparathyroidism. The trial showed that Natpar maintained serum calcium while reducing oral calcium and active vitamin D supplemental doses.
“Chronic hypoparathyroidism can carry a significant disease burden, and some patients are not well-controlled, showing fluctuations in their serum calcium levels,” said Professor Maria Louisa Brandi, Department of Internal Medicine, University of Florence, Italy. “Clinical studies have shown Natpar maintains serum calcium while reducing the need for calcium and vitamin D for patients with chronic hypoparathyroidism.”
With this approval, Shire is now authorized to market Natpar in the 28 Member States of the European Union (EU), as well as in Iceland, Liechtenstein and Norway.
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