Investors in healthcare giants Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NYSE:SNY) were given another reason to smile earlier today as the companies officially announced that the European Commission has granted them the right to begin marketing Praluent, their new cholesterol-lowering medication, for sale. Praluent, or alirocumab, is used in treating what is known as “bad cholesterol” or low density lipoprotein cholesterol, in adults that have the presence of high levels of cholesterol in the blood. It will be available in single-doses as a pre-filled pen which patients can easily self-administer.
Advertisement
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.
Specifically, the drug has been green-lighted for treatment of primary hypercholesterolaemia or mixed dyslipidaemia as an adjunct to diet, either alongside a statin-based regimen or alone or in combination with other lipid-lowering therapies when statins can not be taken.
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%. Many in Europe, unfortunately, have poor control of their LDL levels, despite a number of lipid-lowering treatments available. For a few of these patients, additional treatment options are needed to more aggressively lower their cholesterol. The cholesterol management market offers huge commercial potential and Praluent is expected to generate multi-billion revenues. Patients who initially started on Praluent 75 mg every two weeks experienced average LDL-cholesterol reductions from baseline ranging from 44.5 per cent to 49 per cent at week 12. An extended version of the ODYSSEY trials looks to also measure Praluent’s efficacy in long-term reduction of cardiovascular disease events, with results predicted for 2017. Hazard ratios were calculated post-hoc; HR=0.52 (95 per cent CI, 0.31 to 0.90). It is the leading cause of death worldwide. Scientists have not yet determined the effect of Praluent on cardiovascular morbidity and mortality.
Advertisement
This medicinal product is subject to additional monitoring.
