Shire has received conditional marketing authorisation from the European Commission (EC) for Natpar (rhPTH / 1-84), a recombinant human protein with the full-length, 84-amino acid sequence of endogenous parathyroid hormone (PTH).
Natpar is a hormone therapy available as a once-daily injection in multiple doses indicated as an adjunctive treatment for adult patients with chronic hypoparathyroidism, which cannot be adequately controlled with standard therapy alone.
Hypoparathyroidism is an endocrine disease when parathyroid glands secrete inadequate levels of PTH leading to a mineral imbalance in the body with a low concentration of calcium (hypocalcemia) and a high concentration of phosphate (hyperphosphatemia) in the blood.
Shire Global head of research and development Philip Vickers said: “As the first and only licensed recombinant parathyroid hormone treatment in Europe for chronic hypoparathyroidism, Natpar represents a historical and timely innovation for patients who cannot be adequately controlled on calcium and vitamin D alone.
“The approval of Natpar offers an important advance in the management of this rare endocrine disorder for patients in Europe.”
The conditional marketing authorisation has been issued on the basis of the results of Phase III efficacy and safety of rhPTH (1-84) clinical trial (REPLACE) in patients within the age group of 19-74 years affected with chronic hypoparathyroidism.
The trial test exhibited that Natpar maintained serum calcium and reduced oral calcium and active vitamin D supplemental doses.
University of Florence department of internal medicine Professor Maria Louisa Brandi said: “Chronic hypoparathyroidism can carry a significant disease burden, and some patients are not well-controlled, showing fluctuations in their serum calcium levels.
“Clinical studies have shown Natpar maintains serum calcium while reducing the need for calcium and vitamin D for patients with chronic hypoparathyroidism.”
The approval authorises Shire to market Natpar in all the 28 member states of EU including Iceland, Liechtenstein and Norway.
Natpar is already approved in the US, where it is commercialised under the name Natpara.