Amgen Announces Top-Line Results Of Phase 3 Sensipar®/Mimpara® EVO... (ng or when walking achy and stiff joints...)

Amgen Announces Top-Line Results Of Phase 3 Sensipar®/Mimpara® EVOLVE™ Trial

Date:6/8/2012

ng or when walking, achy and stiff joints, muscle weakness, and complaints of dry, itchy skin are common. Advanced disease is marked by very large parathyroid glands that may need to be removed by surgery.

About Sensipar/Mimpara (cinacalcet)

Cinacalcet is approved in more than 50 countries and marketed as Sensipar in the United States (U.S.), Canada, Australia and New Zealand and as Mimpara in the European Union and other countries. Sensipar/Mimpara is the first oral calcimimetic agent approved for the treatment of secondary HPT in CKD patients receiving dialysis. The therapy is also approved by the U.S. Food and Drug Administration, European Medicines Agency and Health Canada for hypercalcemia in patients with parathyroid carcinoma and severe hypercalcemia in patients with primary HPT who are unable to undergo parathyroidectomy. Sensipar/Mimpara binds to the calcium-sensing receptor, which causes the receptor to become more sensitive to extracellular calcium ions. This results in a drop in PTH levels by inhibiting PTH synthesis and secretion. In addition, the reductions in PTH lower serum calcium and phosphorus levels.

Secondary HPT Indication
Sensipar is indicated for the treatment of secondary HPT in patients with CKD on dialysis.

Primary HPT Indication
Sensipar is indicated for the treatment of severe hypercalcemia in patients with primary HPT who are unable to undergo parathyroidectomy.

Important Safety Information

Sensipar lowers serum calcium; therefore, it is important that patients are carefully monitored for the occurrence of hypocalcemia. Sensipar should not be initiated if serum calcium is less than the lower limit of the normal range. Significant reductions in calcium may lower the threshold for seizures. In the treatment of secondary hyperparathyroidism the most commonly reported side effects in clinical trials were nausea, vomiting, and diarrhea. In the treatment of primary hyperthyroidis
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SOURCE Amgen
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