The application is based on results presented in March at the 67th Scientific Session of the American College of Cardiology.
Sanofi and Regeneron announced today that FDA has accepted a supplemental Biologics License Application for alirocumab, the powerful anticholesterol therapy sold as Praluent.
The application was anticipated after the presentation in March of results from the ODYSSEY OUTCOMES trial of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, which found a 15% overall reduction in major adverse cardiovascular (CV) events, including heart attack, stroke, CV death, and unstable angina that requires hospitalization.
The study showed that the therapy was especially effective in patients who started the study with low-density lipoprotein (LDL) cholesterol levels of at least 100 mg/dL; for this group, major CV events were reduced 29%.
FDA previously expanded approval of the other PCSK9 inhibitor on the market, evolocumab (Repatha), to include the prevention of heart attacks, strokes, and coronary revascularizations. That indication was based on results from the FOURIER trial, which found a 15% overall reduction in major CV events but did not find a reduction in CV death.
Under the Prescription Drug Use Fee Act, FDA must act on the application by April 28, 2019.
Sanofi and Regeneron noted in their statement today that FDA had recently approved dosing information for patients with heterozygous familial hypercholesterolemia who are undergoing apheresis treatment, a procedure in which LDL cholesterol is removed the blood. The recommended dose of alirocumab in patients undergoing LDL apheresis is 150 mg once every 2 weeks. Alirocumab can be administered without regard to timing of apheresis.
Earlier this year, the companies reached a deal with Express Scripts to make alirocumab the exclusive PCSK9 inhibitor on the pharmacy benefit manager's national formulary, presumably at a price between $4500 and $8000 per year, which would be in line with findings from the Institute for Clinical and Economic Review of the drug's value. Sales of both PCSK9 inhibitors have fallen short of expectations after both were launched 3 year ago at prices above $14,000 a year.