Sanofi and Regeneron Announce Praluent Approval in EU for Hypercholesterolemia TreatmentDaniel McCarthy (Author) Published Date : Sep 28, 2015 22:02 IST
Sanofi and Regeneron Pharmaceutical announced on Monday that they were granted approval to market Praluent by the European Commission. Praluent or alirocumab is used in treating what is known as bad cholesterol or LDL low density lipoprotein cholesterol, in adults that have hypercholesterolemia. The medication is the only PCSK9 EC-approved inhibitor available in two doses as a single injection of 1-milliter (75 and 150 mg) once every 14 days, offering two levels of overall efficacy.
Praluent is to be available in a single dose pen that is pre-filled that patients can use to self-administer.
The availability of the two different dosing strengths of Praluent provides for flexibility in dosing and in clinical practice will enable doctors to tailor their treatment based up the individual patient s needs for lowering of LDL cholesterol, said a doctor in France.
In the different Phase III trials, most of the patients starting on the lower 75 mg Praluent dose achieved their LDL-cholesterol pre-defined goals and were able to maintain treatment at the same does during the entire period of assessment.
The EC approved the use of Praluent for treating patients that have primary hypercholesterolemia who are adults.
High cholesterol is a heath concern of significant proportion across Europe. 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 cholesterol is a big risk factor in the development of cardiovascular disease, which is still the leading cause of death worldwide.
Despite treatments using the standard care products including statins as well as other lipid-lowering treatments, many Europeans still have poorly controlled levels of LDL-cholesterol including those with high CV risk, HeFH and or with a statin intolerance history.
For a portion of those patients, other treatment options are required to lower cholesterol more aggressively.
Sanofi and Regeneron Announce Praluent Approval in EU for Hypercholesterolemia Treatment