Regeneron and Sanofi Announce FDA Approval of Praluent Injection, the First PCSK9 Inhibitor in the US, for the Treatment of High LDL Cholesterol in Adult Patients

Regeneron Pharmaceuticals and Sanofi have announced that FDA has approved Praluent (alirocumab) Injection, the first FDA-approved treatment in a new class of drugs known as PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors. Praluent is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein (LDL) cholesterol. The effect of Praluent on cardiovascular morbidity and mortality has not been determined.

Praluent is the first and only PCSK9 inhibitor approved in the US and is available in two different doses (75 mg and 150 mg). Both doses of Praluent are available in a single 1-mL injection delivered in a single-dose prefilled pen or syringe that patients self-administer every 2 weeks.

"For patients with high LDL, or bad, cholesterol the primary focus of treatment is to lower their levels, but many patients today do not achieve recommended levels despite lifestyle modifications and treatment with statins," said Christopher Cannon, Professor of Medicine at Harvard Medical School, Cardiovascular Division at Brigham and Women's Hospital, and a member of the Steering Committee for the Phase III ODYSSEY clinical trial program. "In the ODYSSEY clinical trial program, two doses of alirocumab showed significant LDL cholesterol lowering in a variety of patients who were not able to adequately lower their LDL cholesterol with current standard of care alone. The majority of patients achieved their LDL-lowering goals with the 75 mg dose, when added to maximally tolerated dose of a statin, with a generally acceptable safety profile."

"Despite significant progress over the last decades, high cholesterol remains a leading concern in the US and globally," said Olivier Brandicourt, CEO, Sanofi. "Praluent demonstrates the power of the Sanofi and Regeneron alliance to deliver a first-in-class therapy in the US for patients in need. Sanofi has a strong cardiovascular heritage and dedication to these patients, and we look forward to working with other regulatory authorities to make Praluent available to patients worldwide."

"We are grateful to the thousands of patients and investigators worldwide who participated in the ODYSSEY clinical trial program," said Leonard S. Schleifer, Founder, President, and CEO, Regeneron. "Praluent represents the culmination of more than a decade of tireless work to translate the genetic-based discovery of PCSK9 into an innovative medicine that brings meaningful value to patients."