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The agency’s CHMP recommended conditional marketing authorization for the hormone replacement therapy for the treatment of chronic hypoparathyroidism.
The European Medicines Agency (EMA) announced on Feb. 24, 2017 that its Committee for Medicinal Products for Human Use (CHMP) has granted conditional marketing authorization in the European Union to Natpar (parathyroid hormone) for the treatment of chronic hypoparathyroidism. Natpar received an orphan designation from the Committee for Orphan Medicinal Products (COMP) in 2013, and is the first approved replacement therapy to treat patients with chronic hypoparathyroidism that cannot be adequately controlled with calcium and vitamin D.
Results from a clinical trial, where 124 randomly selected participants were given either Natpar or a placebo in addition to the standard treatment with calcium and vitamin D, showed that 54.8% of participants treated with Natpar could reduce the doses of calcium and vitamin D supplements by more than 50% while maintaining acceptable blood-calcium levels, compared to 2.5% of participants who received the placebo treatment.
Conditional approval allows EMA to recommend a drug for authorization before all clinical trial data have been obtained because the agency feels the benefits of the drug outweigh the risks that may come with incomplete data. The conditional approval requires Shire Pharmaceuticals Ireland Limited to conduct a 26âweek clinical trial to further study the safety and efficacy of Natpar.
Natpar is a daily administered hormonal injection that replaces some of the parathyroid hormone missing in patients with hypoparathyroidism, which helps to restore calcium and phosphate levels. Hypoparathyroidism, which is a hormone disorder where the parathyroid glands don’t produce enough parathyroid hormone, can affect normal nerve and muscle function and lead to possible bone fractures and calcium deposits.