First hormone replacement therapy approved for parathyroid disorder

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The European Medicines Agency has recommended conditional marketing authorisation for the orphan medicine, Natpar.

The orphan drug Natpar (parathyroid hormone) is expected to receive marketing authorisation in Europe in the near future, after it received approval from European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) last week.

Natpar will be the first approved parathyroid hormone replacement therapy for patients with chronic hypoparathyroidism that is inadequately controlled with standard treatment with calcium and vitamin D.

The CHMP recommended conditional approval for Natpar. Conditional approval is one of the EMA’s main mechanisms to facilitate earlier access to medicines that fulfil unmet medical needs. It allows marketing authorisation before all data from clinical trials become available, if the benefits of making this medicine available to patients immediately outweigh the risks inherent in the lack of comprehensive data.

The safety and effectiveness of Natpar were evaluated in a randomised clinical trial of 124 participants. Almost 55 per cent of participants treated with Natpar were able to reduce doses of calcium and vitamin D supplements by more than 50 per cent while maintaining acceptable serum calcium levels, compared to 2.5 per cent of participants who received placebo.

The CHMP opinion will now be sent to the European Commission for consideration.

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