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EMA recommends conditional marketing authorisation for Natpar in EU

Xinhua, February 25, 2017 Adjust font size:

The European Medicines Agency (EMA) on Friday recommended approving a conditional marketing authorisation for Natpar, a medicine used to treat hypoparathyroidism, in the European Union (EU).

Hypoparathyroidism is a hormone disorder where the parathyroid glands in the neck produce too little parathyroid hormone. This results in too little calcium and too much phosphate in the blood.

Natpar is identical to human parathyroid hormone and an injection of it replaces, to some extent, the missing hormone in patients with hypoparathyroidism, thus helping to restore calcium and phosphate levels.

According to EMA, conditional approval allows the agency to recommend a medicine for marketing authorization before all data from clinical trials become available, if the benefits of making the medicine available to patients immediately outweigh the risks inherent in the lack of comprehensive data.

The EMA's Committee for Medicinal Products for Human Use (CHMP) will now send the recommendation to the European Commission for a decision on an EU-wide marketing authorisation. Endit