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Indication for reduction in CV outcomes sought for evolocumab

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As a result of the FOURIER trial, Amgen announced the submission of a supplemental Biologics License Application to the FDA seeking a new indication for reduction of CV events, including MI, stroke and coronary revascularization, for evolocumab when added to statin therapy.

Amgen also announced it is seeking a variation to the marketing authorization from the European Medicines Agency for evolocumab (Repatha), a PCSK9 inhibitor.

The results of the FOURIER trial showed that reducing LDL levels with evolocumab added to statin therapy confers additional reduction in major CV events such as MI, stroke and coronary revascularization.

“Despite optimized therapy, including high-intensity statins, patients in our landmark [CV] outcomes study were still at high risk for an additional [CV] event,” Sean E. Harper, M.D., executive vice president of research and development at Amgen, said in the press release. “This demonstrates a significant unmet need, as event rates in the real world are typically two to three times higher than those seen in clinical trial settings.”

In FOURIER, adding evolocumab to statin therapy was associated with a 20% (P < .001) reduction in time to first MI, stroke or CV death, and a 15% reduction (P < .001) in the primary endpoint, including hospitalization for unstable angina, coronary revascularization, MI, stroke and CV death.

Evolocumab was also associated with a 27% reduced risk for MI (P < .001), a 21% reduction in stroke risk (P = .01) and a 22% risk reduction for coronary revascularization (P < .001), according to the release.

The study showed no observed effect on CV mortality or hospitalization for unstable angina.

During follow-up of approximately 60,000-patient years, there were no new safety concerns and no differences noted between treatment arms in the overall rate of adverse events, serious adverse events or adverse events that led to study drug discontinuation, according to the release.

“These regulatory submissions are important steps forward to helping improve access for patients who remain at high risk for [CV] events,” Harper said in the release. “We look forward to working with the FDA and EMA to update the labels for Repatha.”

Disclosure: Harper is an employee of Amgen.