Regeneron Pharmaceuticals and Sanofi announced Monday that Praluent has received approval from the European Commission (EC) as treatment for bad cholesterol in adults diagnosed with hypercholesterolemia.
The only proprotein convertase subtilisin/kexin type 9 inhibitor approved by the EC, Praluent is going to be offered in two doses (75mg and 150mg), each of which will come in a single-dose injection that can be administered by patients themselves every two weeks. By offering two levels of doses of the drug, Regeneron and Sanofi are making it possible for doctors to come up with a treatment plan depending on an individual patient's needs.
Praluent is approved for use alone or in combination with a statin or a statin plus other therapies that lower lipids to help achieve ideal low-density liprotein (LDL) levels. It may also be used by those who are statin-intolerant or for whom statin use is contraindicated.
High cholesterol levels is a major health concern in Europe, with the World Health Organization saying the continent has the highest level of prevalence of high cholesterol per capita in the globe. High levels of bad cholesterol, or LDL, is a major risk factor for cardiovascular disease, which is the top cause of death in the world. Many in Europe, unfortunately, have poor control of their LDL levels, despite a number of lipid-lowering treatments available.
"We are pleased to bring Praluent to European patients in need of further LDL-cholesterol lowering," said [pdf] Leonard S. Schleifer, M.D., Ph.D., CEO, president and founder for Regeneron.
The EC approval was given using data from 10 Phase 3 trials, half of which were ezetimibe-controlled and the other half placebo-controlled. Based on results, Praluent offered dramatic reductions in LDL-cholesterol levels compared to ezetimibe or placebo when used alongside standard statins. All 10 of the trials were able to meet their primary efficacy endpoints, showing significant reductions in LDL-cholesterol from baseline levels until the 24th week.
In the trials, those who initially began with 75-mg doses of Praluent were able to reduce their average LDL-cholesterol levels by up to 49 percent within 12 weeks. Those who started with 150-mg doses were able to reduce their average LDL-cholesterol levels by up to 63 percent by week 12.
Praluent was approved for use in the United States in July 2015, prescribed alongside dietary modifications and statin therapy to optimize cholesterol-lowering effects.
Photo: Shimelle Laine | Flickr
