ODYSSEY ESCAPE Top-line Results: Alirocumab Reduces HFH-Related Apheresis Therapy

Deborah Brauser

March 23, 2016

PARIS, FRANCE and TARRYTOWN, NY — Adding the proprotein convertase subtilisin kexin 9 (PCSK9) inhibitor alirocumab (Praluent, Sanofi/Regeneron Pharmaceuticals) biweekly injection to standard treatment can help patients with heterozygous familial hypercholesterolemia (HFH) decrease how often they need to undergo apheresis therapy, suggests new research[1].

Top-line results from the multicenter ODYSSEY ESCAPE trial, which were released today, showed that HFH patients in the alirocumab/standard-therapy group reduced apheresis frequency, the primary efficacy end point, by 75% vs those who received placebo plus standard therapy (P<0.0001).

Apheresis removes LDL cholesterol from the blood, in a procedure reminiscent of kidney dialysis, and can be needed as often as weekly in those with HFH. However, the need for any apheresis treatment at all was completely stopped in 63% of the alirocumab group vs none of the placebo group.

In their joint release, the manufacturers noted that apheresis therapy can cost a patient as much as $100,000 per year—and that there are currently only about 60 centers in the US that provide the procedure.

Fatigue was the most common treatment-related adverse event reported by the ODYSSEY ESCAPE participants, affecting 15% of the alirocumab group vs 10% of the placebo group. Other adverse events included nasopharyngitis in 10% of each group, as well as diarrhea (10% vs 0%, respectively), myalgia (10% vs 5%), and headache (7% vs 5%).

Detailed results from ODYSSEY ESCAPE, which included 62 patients from the US and Germany, will be presented at future conferences, although not at the upcoming American College of Cardiology (ACC) 2016 Scientific Sessions. This substudy is part of the 25,000-person-strong ODYSSEY series of trials.

In related news, a Delaware jury ruled earlier this month for Amgen in its suit against Regeneron and Sanofi, according to a press release[2]. Amgen makes rival PCSK-9 inhibitor evolocumab (Repatha) and charged in federal court that alirocumab infringed upon its patents. The jury agreed, and a future hearing will decide on damages and a possible injunction.

However, a press release at the time from Regeneron noted its strong disagreement with the verdict and its plans to appeal, adding that Amgen's claims "are invalid"[3].

As reported by heartwire from Medscape, the US Food and Drug Administration (FDA) approved alirocumab in July 2015 and approved evolocumab the following month.

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