Sanofi lands EC approval for its cholesterol-busting Praluent

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. Based on results, Praluent offered dramatic reductions in LDL-cholesterol levels compared to ezetimibe or placebo when used alongside standard statins. Praluent is the only EC-approved PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor available in two initial doses as a single 1-milliter (mL) injection (75 mg and 150 mg).

Michel Farnier, M.D., Ph.D., Point Medical, Dijon, France, was quoted as saying, “The availability of two different Praluent dosing strengths provides for dosing flexibility”. He said that it was quite exciting for them to see that numerous patients, many who still had high LDL-cholesterol even after the treatment with other drugs, achieved cholesterol lowering goals within just weeks of including Praluent in their treatment regime.

The EC approved the use of Praluent for treating patients that have primary hypercholesterolemia who are adults. 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. According to World Health Organization data, the continent has the largest prevalence per capital of high bad-cholesterol or LDL of anywhere in the world at 54%, followed by the Americas at 48%.

High LDL-cholesterol is among the major risk factors for cardiovascular disease (CVD).

Olivier Brandicourt, M.D., Chief Executive Officer, Sanofi 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”. For some of these patients, additional treatment options are needed to more aggressively lower their cholesterol. The Phase 3 trials had a number of patients starting on the 75 mg dose & still achieving the LDL-cholesterol goals while maintaining treatment at the low dose through the assessment period. Those who started with 150-mg doses were able to reduce their average LDL-cholesterol levels by up to 63 percent by week 12. Now, the pair’s latest success lies in their cardiovascular targeted drug alirocumab (Praluent) which has been developed to treat hypercholesterolemia. Praluent was generally well-tolerated with an acceptable safety profile.