Amgen on GAUSS-3: Evolocumab Meets LDL-Based Primary End Points in Statin-Intolerant Patients

February 05, 2016

THOUSAND OAKS, CA — Reflecting shorter-term results in a prior trial, the phase 3 Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3 (GAUSS-3) trial "met its co–primary end points," Amgen said in a statement aimed at the investment community[1].

It means that one of its highest-profile products, evolocumab (Repatha), already on the market, cut mean LDL-C levels significantly further than treatment with ezetimibe over 24 weeks in patients who had been intolerant of statin therapy due to "muscle-related side effects," which usually means pain or spasms.

"There were no new safety findings," the company said.

As is customary in such announcements, relative outcomes implying a significant difference were provided without specific numbers. GAUSS-3, randomized and with double-blinding, is reported to have enrolled 519 patients.

Evolocumab, a human monoclonal antibody for proprotein convertase subtilisin-kexin type 9 (PCSK9), lowers LDL-C via an entirely different mechanism compared with statins or ezetimibe.

The approvals of evolocumab and a competing PCSK9 inhibitor alirocumab (Praluent, Sanofi/Regeneron) indicated them for LDL-C lowering in conjunction with maximally tolerated statins. Approval in the statin-intolerant population tested in GAUSS-2 and GAUSS-3 would expand the indication to a modestly broader population.

Amgen is sponsoring a large cardiovascular-outcomes trial it hopes will settle the big PCSK9-inhibitor question in the medical community, whether the LDL-C-lowering shown by these drugs—evolocumab in this case—can translate to fewer CV events. Top-line results from such a trial, called FOURIER, which randomized about 27,500 patients with clinical cardiovascular disease, "are anticipated in the second half of 2016," according to the company.

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