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%.
ODYSSEY OUTCOMES study shows alirocumab most effective in those with highest LDL cholesterol.
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.
Dr Kathryn Lindley Explains the Importance of Cardio-Obstetrics in Fellowship Programs
December 5th 2023Kathryn Lindley, MD, FACC, Vanderbilt University Medical Center, talks about why it’s important to incorporate cardio-obstetrics training into cardiovascular disease fellowship programs.
Read More
For National Women’s Health Week, One Company Emphasizes Cardiovascular Risk Management
May 10th 2022On this episode of Managed Care Cast, we speak with Joanne Armstrong, MD, MPH, vice president and chief medical officer for Women’s Health and Genomics at CVS Health, on the distinct pathophysiology of cardiovascular disease in women and how her own health experiences have influenced her perspective on cardiovascular disease management.
Listen
In this interview with The American Journal of Managed Care®, Katie Queen, MD, addresses the complexity of obesity as a medical condition, pivoting to virtual care while ensuring that patients who lived in a rural location continued to receive adequate care, and the importance of integrating awareness of obesity and chronic disease prevention into local food culture.
Read More