Sanofi and Regeneron’s Praluent accepted for EU review

Sanofi and Regeneron have announced that their new cholesterol therapy Praluent has been approved for European regulatory review.

The European Medicines Agency has accepted for review a marketing authorisation application that will see the investigational monoclonal antibody targeting PCSK9 assessed as a means of treating patients with hypercholesterolaemia.

This application is based on positive clinical data collated from more than 5,000 patients, including ten phase III trials from the Odyssey programme, as well as additional ongoing studies including Odyssey Outcomes.

Including more than 23,500 patients at more than 2,000 study centres, this programme of double-blind, randomised, placebo and active-controlled trials ranged in length from 24 weeks to approximately five years.

Praluent is the proposed brand name for a therapy that was known during the development stage as alirocumab. Clinical data reported earlier this month showed that the drug can help patients reach optimal cholesterol levels via a monthly dosing regimen.