Sanofi and Regeneron given European nod for Praluent
pharmafile | September 28, 2015 | News story | Sales and Marketing | European Commission, Regeneron, Sanofi, alirocumab, high cholesterol, marketing authorisation, praluent
The European Commission (EC) has approved the marketing authorisation of Sanofi and Regeneron’s cholesterol drug Praluent.
The heart drug is approved across the continent for the treatment of low-density lipoprotein (LDL) cholesterol in certain adult patients with hypercholesterolemia.
The EC approved Praluent (alirocumab) for the treatment of adult patients with primary hypercholesterolemia or mixed dyslipidemia as an adjunct to diet in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach their LDL-cholesterol targets.
Praluent is the only EC-approved drug of this type – called proprotein convertase subtilisin/kexin type 9, or (PCSK9) inhibitors – that is available in two starting doses.
The EC decision is based on data from Sanofi’s Phase III ODYSSEY trials, which showed reductions in LDL-cholesterol for Praluent compared to placebo or ezetimibe, when added to current standard-of-care.
Sanofi chief executive Olivier Brandicourt says: “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. It was very exciting for us to see that the majority of these patients, most of whom continued to have very high LDL-cholesterol despite treatment with other lipid-lowering drugs, were able to achieve their cholesterol-lowering goals within weeks of adding Praluent to their treatment regime.”
While Leonard Schleifer, founder, president, and chief executive of Regeneron says: “We are pleased to bring Praluent to European patients in need of further LDL-cholesterol lowering. This approval was made possible through the tremendous hard work of our innovative scientists who translated a genetics-based discovery into an important new medicine, as well as thousands of dedicated investigators and patient participants.”
According to the WHO Europe has the highest prevalence of high cholesterol in the world at 54%. Sanofi is looking to bolster its clinical case for Praluent by running an ongoing cardiovascular outcomes trial, with results anticipated in 2017, to investigate whether the drug reduces the chances of major heart problems.
Yasmita Kumar
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