Sanofi’s cholesterol drug Praluent (alirocumab) has been recommended for European approval, putting it on-course to catch up with Amgen’s rival treatment Repatha (evolocumab).
The two PCSK9 inhibitors offer new options for the treatment of high cholesterol – for which there have been few effective therapies since the introduction of statins.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) backed Praluent to lower high levels of cholesterol in people who are unable to control their cholesterol despite taking optimal doses of statins or who cannot take statins.
Praluent and Repatha have been in a race to reach the market, with Repatha recommended by the CHMP in May and approved in Europe just last week.
Meanwhile, Praluent’s CHMP recommendation came on the same day that Sanofi received FDA approval for its drug, pulling into the lead in the US, the world’s largest market.
Praluent works by blocking the PCSK9 protein, which would otherwise lower the number of LDL-receptors in the liver and so diminish its ability to remove LDL-cholesterol (‘bad cholesterol’) from the blood.
The drug’s CHMP recommendation came on the back of a series of phase III trials showing it reduced LDL-cholesterol in patients with hypercholesterolaemia and mixed dyslipidaemia.
The EMA advisors also looked at safety information from over 3,300 patients treated with Praluent and considered the drug’s safety profile to be acceptable, with few patients discontinuing treatment or showing serious adverse events.
Elias Zerhouni, president, Global R&D at Sanofi, said: “We are very pleased to receive a positive opinion from the CHMP for Praluent, and look forward to bringing Praluent to those in greatest need across Europe.
“Despite statins and other lipid-lowering therapies, many patients are unable to reach their LDL cholesterol goals, and may benefit from new therapeutic options such as Praluent.”
The company said it expects a final decision from the European Commission on Praluent’s marketing authorisation application in late September.