Amgen's Mimpara approved by EC

US biotechnology major Amgen has announced that the European Commission has approved the extension of the marketing authorization in the European Union for Mimpara (cinacalcet).

Mimpara, also known as Sensipar in the USA, Australia, New Zealand and Canada, is now approved for the reduction of hypercalcemia in patients with primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but in whom this procedure is not clinically appropriate or is contra-indicated. The approval is based on a review by the Committee for Medicinal Products for Human Use (CHMP), which concluded that Mimpara fulfills an unmet medical need.

PHPT is an endocrine disorder caused by the enlargement of one or more of the four parathyroid glands and resulting in the release of excess parathyroid hormone (PTH). PTH regulates the amount of calcium and phosphorus in the body and plays an important role in several body systems, including the skeletal, gastrointestinal, renal, muscular and central nervous systems. The majority of patients with PHPT requiring an intervention are treated surgically by parathyroidectomy. However, this is not a suitable option for a small proportion of patients.