FDA News

FDA agrees to consider CV outcomes indication for alirocumab

Regeneron and Sanofi announced that the FDA has agreed to review its supplemental biologics license application to add an indication stating alirocumab improves CV outcomes.

The application was submitted to update the prescribing information of the PCSK9 inhibitor injection alirocumab (Praluent, Sanofi/Regeneron) to include that it reduces the overall risk for major adverse CV events, defined as MI, ischemic stroke, death from CHD and unstable angina that requires hospitalization, according to a press release from the companies.

The application is supported by data from the ODYSSEY Outcomes trial, which was presented at the American College of Cardiology Scientific Session in March.

As Cardiology Today previously reported, reducing LDL to very low levels with alirocumab lowered risk for major adverse CV events and all-cause mortality in patients with ACS on statin therapy.

The effects on CV morbidity and mortality have not been evaluated in its entirety by any regulatory authority, according to the press release.

Prescribing information for alirocumab has recently been updated to include clinical information for patients with heterozygous familial hypercholesterolemia. The recommended dose for those who are undergoing LDL apheresis is 150 mg once every 2 weeks regardless of the timing of apheresis, according to the release.

This update was supported by data from ODYSSEY ESCAPE, which assessed the treatment in 62 patients with heterozygous FH.

The Prescription Drug User Fee Act action date for the CV outcomes indication for alirocumab has been set by the FDA for April 28, 2018, according to the release.

Regeneron and Sanofi announced that the FDA has agreed to review its supplemental biologics license application to add an indication stating alirocumab improves CV outcomes.

The application was submitted to update the prescribing information of the PCSK9 inhibitor injection alirocumab (Praluent, Sanofi/Regeneron) to include that it reduces the overall risk for major adverse CV events, defined as MI, ischemic stroke, death from CHD and unstable angina that requires hospitalization, according to a press release from the companies.

The application is supported by data from the ODYSSEY Outcomes trial, which was presented at the American College of Cardiology Scientific Session in March.

As Cardiology Today previously reported, reducing LDL to very low levels with alirocumab lowered risk for major adverse CV events and all-cause mortality in patients with ACS on statin therapy.

The effects on CV morbidity and mortality have not been evaluated in its entirety by any regulatory authority, according to the press release.

Prescribing information for alirocumab has recently been updated to include clinical information for patients with heterozygous familial hypercholesterolemia. The recommended dose for those who are undergoing LDL apheresis is 150 mg once every 2 weeks regardless of the timing of apheresis, according to the release.

This update was supported by data from ODYSSEY ESCAPE, which assessed the treatment in 62 patients with heterozygous FH.

The Prescription Drug User Fee Act action date for the CV outcomes indication for alirocumab has been set by the FDA for April 28, 2018, according to the release.