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news.The US FDA has approved Sanofi and Regeneron Pharmaceuticals' Praluent (alirocumab) Injection as an adjunct to diet and maximally tolerated statin therapy to treat adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease (ASCVD).
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The drug is approved for adults who require additional lowering of low-density lipoprotein (LDL) cholesterol.
Praluent is the FDA-approved treatment in a new class of drugs known as PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors.
According to the companies, the effect of Praluent on cardiovascular morbidity and mortality has not been determined.
In the US, Praluent is available in two different doses (75mg and 150mg) in a single 1mL injection delivered in a single-dose prefilled pen or syringe that patients self-administer every two weeks.
The approval was based on data from the pivotal Phase III Odyssey program, 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 150mg every two weeks, the drug 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 75mg 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.
In this study, if additional LDL cholesterol lowering was required based on pre-specified criteria at week eight, Praluent was up-titrated to 150mg at week 12 for the remainder of the trial. About 83% of patients remained on their initial 75mg dose.
Separately, the European Medicine Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorization of Praluent, recommending its approval for use in certain adult patients with hypercholesterolemia.