Shire PLC's Natpar, an adjunctive treatment for adult patients with chronic hypoparathyroidism, was reviewed positively by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
“This endorsement by the EMA is a critical step towards addressing an unmet need for patients with chronic hypoparathyroidism,” Dr. Philip Vickers, head of R&D for Shire, said in a statement. “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 European Commission, which designated hypoparathyroidism an orphan disease, is expected to make a final decision on whether to provide Natpar a conditional marketing authorization. It will consider the CHMP’s positive opinion when making the decision.
“Hypoparathyroidism is the last endocrine disorder for which there is no hormone treatment,” Liz Glenister, chief executive of a hypoparathyroid patient organization, said. “There is a high unmet medical need in patients in the E.U. 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.”
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