FDA approves Praluent for the treatment of high LDL cholesterol

Sanofi and Regeneron have announced that the US Food and Drug Administration (FDA) has approved Praluent® (alirocumab) Injection.

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.

“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, M.D., Professor of Medicine at Harvard Medical School. “In the ODYSSEY clinical trial programme, 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.”

Many patients in the US face the challenge of achieving LDL cholesterol levels recommended by healthcare providers, despite treatment with standard of care including statins. These include approximately 8-10 million patients with an inherited form of high LDL cholesterol known as heterozygous familial hypercholesterolemia and those with clinical ASCVD, defined as a build-up of plaque in the arteries which can lead to reduced blood flow and a number of conditions including heart attack, stroke, chest pain (stable or unstable angina), transient ischemic attack, revascularization and peripheral artery disease.

Praluent showed significant LDL cholesterol lowering in trials

The approval of Praluent was based on data from the pivotal Phase 3 ODYSSEY programme, which showed consistent, positive results compared to placebo and included current standard of care therapy (statins). In the ODYSSEY LONG TERM trial which evaluated Praluent 150 mg every two weeks, Praluent reduced LDL cholesterol by 58% versus placebo at week 24 when added to current standard of care, including maximally tolerated statins. In ODYSSEY COMBO I, Praluent 75 mg every two weeks as an adjunct to statins reduced LDL cholesterol by an additional 45% compared to placebo at week 12. At week 24 in the same trial, Praluent reduced LDL cholesterol by an additional 44% compared to placebo.

The European Commission (EC) is expected to make a final decision on the Marketing Authorisation Application for Praluent in the European Union in September.