Praluent, which is being developed by Sanofi and Regeneron Pharmaceuticals, will be available in both a 75 mg and 150 mg dose for self-administration every two weeks.
It will also be available in a single-dose pre-filled pen that patients self-administer.
Data from several clinical trials revealed that LDL-cholesterol was reduced for Praluent compared to placebo or ezetimibe, when added to existing standard-of-care, which included maximally-tolerated statins.
Primary efficacy endpoint was met in all the trials, indicating greater reductions from baseline in LDL-cholesterol at week 24, compared to placebo or ezetimibe. It was well-tolerated with an acceptable safety profile.
Sanofi CEO Olivier Brandicourt said: "Our clinical program 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 approved Praluent as an adjunct to diet and maximally tolerated statin therapy to treat adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease.
Europe leads the greatest prevalence per capita of high cholesterol in the world with 54% followed by the the World Health Organization Region of Americas with 48%.
Image: Line filling – France (Le Trait). Photo: courtesy of Céline Clanet / Interlinks Image.