Regeneron and Sanofi‘s cholesterol treatment, Praluent gets FDA approval

WASHINGTON - July 28, 2015 - PRLog -- The U.S. Food and Drug Administration has approved Praluent (alirocumab) Injection to treat high LDL Cholesterol in adult patients. Praluent was co-developed by Sanofi and Regeneron and is the first approved PCSK9 Inhibitor in a new class of drugs known as PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors. According to the indication, Praluent is to be used as an adjunct to diet and maximally tolerated statin therapy to treat adult patients with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease (ASCVD) and those who need additional lowering of low-density lipoprotein (LDL) cholesterol.

"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, Cardiovascular Division at Brigham and Women's Hospital, and a member of the Steering Committee for the Phase 3 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."

Consistent data from the Phase 3 ODYSSEY program influenced the FDA’s decision for approval. Results confirmed that Praluent was superior to the placebo in reducing LDL cholesterol. Praluent reduced LDL cholesterol by 58 percent versus placebo at week 24 when added to current standard of care, including maximally tolerated statins in the ODYSSEY LONG TERM trial. In ODYSSEY COMBO I assessing Praluent 75 mg every two weeks as an adjunct to statins, LDL cholesterol was lowered by 43 percent at week 24 compared to the placebo.

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