The European Commission granted conditional marketing authorization for Shire’s full-length recombinant human parathyroid hormone Natpar® (rhPTH[1-84]) used as adjunctive therapy in adult patients with chronic hypoparathyroidism whose serum calcium levels can’t adequately be controlled using standard treatment of calcium and vitamin D.
The approval is the first in Europe for a hormone therapy for this indication and was was based on data from the placebo-controlled Phase III REPLACE study. The trial, involving 124 adult patients with chronic hypoparathyroidism, showed that once-daily rhPTH(1-84) therapy maintained serum calcium levels and reduced their required daily doses of oral calcium and active vitamin D supplements.
As part of the conditional marketing authorization for Natpar in Europe, Shire will have to carry out an additional 26-week trial to further evaluate safety and efficacy of the treatment, confirm the dosing schedule, and assess the effects of treatment on disease symptoms and quality of life.
“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,” said Philip J. Vickers, Ph.D., global head of R&D at Shire. “The approval of Natpar offers an important advance in the management of this rare endocrine disorder for patients in Europe.”
FDA approved rhPTH(1-84), registered as Natpara®, in January 2015. Clearance in the U.S. was tied to a Risk Evaluation and Mitigation Strategy (REMS) program and black box warning relating to the increased risk of osteosarcoma associated with Natpara therapy. The drug was commercialized in the U.S. by NPS Pharma, which Shire announced just weeks before the FDA decision that it was buying in a deal valued at some $5.2 billion.