logo
Share SHARE
FONT-SIZE Plus   Neg

Amgen Reports Top-Line Results Of Phase 3 Sensipar/Mimpara EVOLVE Trial

Amgen Inc. (AMGN) announced top-line results of the Phase 3 EVOLVE trial, evaluating Sensipar/Mimpara for the reduction of the risk of mortality and cardiovascular or CV events among 3,883 patients with secondary hyperparathyroidism and chronic kidney disease receiving dialysis.

The trial's primary endpoint was time to the composite event comprising all-cause mortality or first non-fatal cardiovascular event, including myocardial infarction, hospitalization for unstable angina, heart failure or peripheral vascular event. Though patients in the Sensipar/Mimpara arm experienced numerically fewer composite primary events, the results were not statistically significant, and the study failed to meet its primary endpoint in the intent-to-treat analysis.

"Amgen embarked on the EVOLVE trial to understand whether treating secondary HPT with Sensipar/Mimpara could positively impact the high rates of mortality and cardiovascular events among patients with CKD receiving dialysis," said Sean Harper, M.D., executive vice president of Research and Development at Amgen.

The most frequently reported adverse events in the Sensipar/Mimpara arm of the trial were consistent with the known safety profile of this therapy and included nausea, vomiting and hypocalcemia.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Amgen reported an increase in second-quarter profit, driven by sales of arthritis drug Enbrel and osteoporosis treatments Xgeva and Prolia, and improved margins. Both earnings and sales topped Wall Street estimates. Electronic Arts Inc. (EA) on Thursday reported an increase in profit for the first quarter, reflecting continued strong digital revenues, with both earnings and revenues topping Wall Street estimates. However, shares of the company fell over 4 percent, after having detailed a weak outlook. Redwood... LinkedIn Corp., the world's largest online professional network, said Thursday after the markets closed that its second quarter loss widened sharply from last year, as higher costs and expenses more than offset a 33% increase in revenue. However, the company's quarterly earnings per share, excluding items, came in well above analysts' expectations as did its quarterly revenue.
comments powered by Disqus
RELATED NEWS
Trade AMGN now with 
Follow RTT