Regeneron Pharmaceuticals & Sanofi announced today that the EC (European Commission) granted marketing authorization for alirocumab (Praluent) for treating bad cholesterol also called LDL (low-density lipoprotein) cholesterol, in adult patients who have hypercholesterolemia. Praluent is the only PCSK9 inhibitor with EC-approval. It will be available in single-doses as a pre-filled pen which patients can easily self-administer.
Michel Farnier, MD., from Point Medical, France said that Praluent will be available in 2 different dose strengths to provide dosing flexibility. This will help physicians tailor treatments based on the LDL-cholesterol-lowering requirements of patients. 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.
Praluent was approved by the EC for treating adult patients with mixed dyslipidemia or hypercholesterolemia along with a diet that combines statin or other lipid-lowering therapies in patients who aren’t able to reach LDL-cholesterol goals or with other lipid-lowering therapies for patients who are intolerant to statin. The effect of this drug on cardiovascular morbidity & mortality hasn’t been determined yet.
High cholesterol is a major health concern throughout Europe. As per the WHO (World Health Organization) Europe has the largest prevalence of high cholesterol per capita in the world at 54%. The high LDL-cholesterol is quite a big risk and can cause cardiovascular disease which is one of the leading causes of death in the world.
Olivier Brandicourt, MD., the CEO of Sanofi said that the clinical program focused on the patients who had the maximum unmet needs with most of them being on maximally-tolerated statins & other lipid-lowering therapies already. He said that it was quite exciting for them to see that many of the 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.
Steven Myers
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