Amgen Annnounces Safety Analysis Of Cholesterol-Lowering Medication Repatha

(RTTNews) - Amgen Inc (AMGN) on Sunday announced one-year data from prespecified exploratory endpoints of adjudicated cardiovascular events in the Phase 2 (OSLER-1) and Phase 3 (OSLER-2) open-label extension studies of Repatha (evolocumab), a novel investigational low-density lipoprotein cholesterol (LDL-C)-lowering medication.

Data from prespecified exploratory endpoints in the ongoing open-label OSLER-1 and OSLER-2 studies showed Repatha plus standard of care (SOC) treatment reduced adjudicated cardiovascular events (0.95 percent Repatha plus SOC; 2.18 percent SOC) over a one-year analysis period.

Adverse events (=1 percent in the Repatha plus SOC group and more frequent in the Repatha plus SOC group by at least 1 percent) included arthralgia, headache, pain in extremity and fatigue.

The cardiovascular events analysis comprises exploratory findings from the ongoing open-label OSLER studies. Repatha plus SOC treatment reduced LDL-C by 61 percent compared to SOC.

These data were presented today at a Late-Breaking Clinical Trial session at the American College of Cardiology's 64th Annual Scientific Session (ACC.15) and published in the New England Journal of Medicine.

A two-year analysis of Repatha safety and tolerability data from the longest proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor trial to date (OSLER-1) was also presented.

The OSLER-1 and OSLER-2 trials are ongoing open-label extension studies designed to characterize long-term effects of Repatha.

The trials enrolled 4,465 patients who had completed one of 12 Phase 2 and 3 Repatha studies, 2,976 of whom were randomized to subcutaneous Repatha 140 mg every two weeks or 420 mg monthly plus SOC therapy and 1,489 were randomized to SOC alone over one year.

Compared to SOC alone, Repatha plus SOC reduced adjudicated cardiovascular events (death, myocardial infarction, unstable angina requiring hospitalization, coronary revascularization, stroke and transient ischemic attack or heart failure requiring hospitalization) compared to SOC alone (0.95 percent Repatha plus SOC vs. 2.18 percent SOC over one year), with a consistent effect on death, coronary and cerebrovascular events as well as by subgroups.

Adverse events with a frequency of at least 1 percent in the Repatha plus SOC arm and that were more frequent with Repatha plus SOC by at least 1 percent included arthralgia, headache, pain in extremity and fatigue.

Data from the OSLER-1 study showed Repatha maintained its efficacy over a two-year period and no safety risk was identified. The study randomized 1,104 patients who completed short-term, double-blind, controlled Repatha studies to receive SOC (n=370) or SOC plus open-label Repatha 420 mg monthly (n=734) for one year.

After the first year, all patients received monthly Repatha plus SOC. At the end of year two, 590 patients were still receiving Repatha, showing a persistence rate of 80 percent. Of the patients on Repatha over the entire two-year period, 33 patients discontinued use due to an AE. Safety and tolerability were comparable regardless of achieved LDL-C level. Low-density lipoprotein cholesterol-lowering was sustained for more than two years, with a reduction of 54 percent at week 52 and 52 percent at week 124.