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Sanofi and Regeneron Pharmaceuticals’ drug Praluent has received marketing authorisation from the European Commission (EC) to treat bad cholesterol, known as low-density lipoprotein (LDL) cholesterol, in certain adult patients with hypercholesterolemia.

Praluent is the only EC-approved proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, and will be available in both 75mg and 150mg doses in a single-dose pre-filled pen for self-administration every two weeks.

The drug is approved to treat adults with primary hypercholesterolemia or mixed dyslipidemia as an adjunct to diet in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach their LDL-cholesterol goals with the maximally tolerated statin.

Praluent is also indicated alone or in combination with other lipid-lowering therapies for patients who are statin-intolerant, or adviced statin is contraindicated.

The company noted that the effect of Praluent on cardiovascular (CV) morbidity and mortality has not yet been determined.

Point Medical Department of Vascular Medicine Dr Michel Farnier said: “The availability of two different Praluent dosing strengths provides for dosing flexibility. In clinical practise, this will enable physicians to tailor treatment based on an individual patient’s LDL-cholesterol-lowering needs.

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“In the Phase III trials, the majority of patients who started on the lower Praluent 75mg dose were able to achieve their pre-defined LDL-cholesterol goals, and maintained treatment at this dose throughout the assessment period.”

The approval was based on data from ten pivotal Phase III Odyssey trials, including five placebo-controlled and five ezetimibe-controlled.

“The majority of patients who started on the lower Praluent 75mg dose were able to achieve their pre-defined LDL-cholesterol goals, and maintained treatment at this dose throughout the assessment period.”

Data from these trials showed consistent, robust reductions in LDL-cholesterol for Praluent compared to placebo or ezetimibe, when added to current standard-of-care, which included maximally-tolerated statins.

The company said that all trials met their primary efficacy endpoint, showing significantly greater reductions from baseline in LDL-cholesterol at week 24, compared to placebo or ezetimibe.

In the placebo-controlled trials, the average LDL-cholesterol reductions from baseline at week 24 for the Praluent group ranged from 46%-61%.

Sanofi CEO Olivier Brandicourt said: “Our clinical programme focused on patients with the highest unmet needs, most of whom were on maximally tolerated statins and/or other lipid-lowering therapies.

“It was very exciting for us to see that the majority of these patients, most of whom continued to have very high LDL-cholesterol despite treatment with other lipid-lowering drugs, were able to achieve their cholesterol-lowering goals within weeks of adding Praluent to their treatment regime.”

In July, the US Food and Drug Administration had approved Praluent as an adjunct to diet and maximally tolerated statin therapy to treat adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease.

Image: Yellow patches consisting of cholesterol deposits above the eyelids are found common in people with familial hypercholesterolemia. Photo: courtesy of Bobtheowl2.