CHMP recommends EU Conditional Marketing Authorisation for Natpar for patients with chronic hypopara

If approved, Natpar would be the first licensed recombinant parathyroid hormone in Europe for the management of chronic hypoparathyroidism, the only endocrine-deficiency disorder with no hormone treatment.

Shire announces that the Committee for Medicinal Products for Human Use (CHMP) of the EMA has adopted a positive opinion recommending the granting of Conditional Marketing Authorisation for Natpar (rhPTH[1-84]), a recombinant human protein with the full length 84–amino-acid sequence of endogenous parathyroid hormone (PTH), as an adjunctive treatment for adult patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone.

Hypoparathyroidism, a designated orphan disease by the European Commission (EC), is a rare disease that occurs when inadequate levels of PTH are secreted by the parathyroid glands, resulting in a mineral imbalance in the body expressed by a low concentration of calcium (hypocalcemia) and high concentration of phosphate (hyperphosphatemia) in the blood.

"This endorsement by the EMA is a critical step towards addressing an unmet need for patients with chronic hypoparathyroidism," said Philip J. Vickers, Head of R&D, Shire. "As a leader in rare diseases, we are committed to advancing therapeutic options for patients with hypoparathyroidism, and we believe that by offering the first recombinant PTH in hypoparathyroidism, we can help patients who are inadequately controlled on standard therapy alone to manage their condition."

The EC will now consider the CHMP positive opinion in its final decision on whether to provide Conditional Marketing Authorisation for Natpar; a final decision from the EC is expected later in 2017.

"Hypoparathyroidism is the last endocrine disorder for which there is no hormone treatment" said Liz Glenister, Chief Executive of a hypoparathyroid patient organization. "Currently, there is a high unmet medical need in patients in the EU who may not be adequately controlled in managing their hypoparathyroidism; those patients are looking forward to this new potential option in the management of their disease."