FDAnews Drug Daily Bulletin

Amgen’s Evolocumab Meets Primary Endpoints in Phase III

Jan. 30, 2014

Amgen’s heart drug evolocumab met its primary endpoints of percent reduction from baseline LDL cholesterol at week 12 and mean percent reduction from baseline low-density lipoprotein (LDL) cholesterol at weeks 10 and 12 in the Phase III LAPLACE-2 study, Amgen said Tuesday.

The randomized, double-blind trial evaluated the PCSK9 inhibitor’s safety, tolerability and efficacy in combination with five statins and as compared to placebo and Merck’s ezetimibe. The drug was analyzed in 1,896 adult patients with high cholesterol at 244 sites across the globe.  Results are consistent with those seen in Phase II trials evaluating evolocumab against placebo and ezetimibe, respectively, in which evolocumab combined with standard of care lowered LDL at a rate up to 66 percent without showing increased adverse events.

Amgen spokesperson Ashleigh Koss told Drug Daily Bulletin that five of Amgen’s 13 Phase III trials of evolocumab, which collectively enroll some 28,000 patients, will form the basis for the company’s global regulatory filing packets. Four of those trials have been completed and the fifth is expected to be completed early this year.

PCSK9 inhibitors bind to the PCSK9 protein and prevent it from targeting LDL receptors for degradation, thereby lowering the levels of LDL in the blood. Roche, Sanofi, Regeneron, Pfizer, Bristol-Myers Squibb, Merck and Alnylam all have PCKS9 inhibitors in various stages of development. — Lena Freund

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