Natpar is a recombinant human PTH and will be available as a 25, 50, 75 and 100 micrograms once-daily injection as adjunctive treatment for adult patients with chronic hypoparathyroidism.
The approval was based on the results from the Phase III efficacy and safety of rhPTH(1-84) REPLACE clinical trial in patients aged 19-74 years with chronic hypoparathyroidism.
REPLACE is a double-blind, placebo-controlled and randomized phase III trial, in which 124 patients with hypoparathyroidism have been randomized in a ratio of 2:1 to either 50 micrograms once daily of rhPTH(1-84) or placebo for 24 weeks.
According to the firm, the study demonstrated that Natpar maintained serum calcium while reducing oral calcium and active vitamin D supplemental doses.
The approval allows Shire to sell Natpar in the 28 member states of the European Union (EU), in addition to Iceland, Liechtenstein and Norway.
In the US, Natpar is marketed under the trade name Natpara (parathyroid hormone).
Shire research and development global head Dr 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.”
Image: Head office of the European Commission. Photo: courtesy of Amio Cajander.