Sanofi and Regeneron report positive data from new Praluent trial

Sanofi and Regeneron have announced new clinical trial data demonstrating the effectiveness of their cholesterol therapy Praluent.

Positive results have been announced from ODYSSEY ESCAPE, a phase III trial evaluating Praluent in patients with an inherited form of high cholesterol known as heterozygous familial hypercholesterolaemia, which requires weekly or bi-weekly apheresis treatment.

It was demonstrated that adding Praluent to existing therapy reduced low-density lipoprotein cholesterol by approximately 50 percent from baseline, compared to a two percent increase for those receiving placebo.

Additionally, the drug was shown to help significantly reduce the need for apheresis treatment by 75 percent compared to placebo, thereby meeting the primary endpoint of the study.

This is an important advance, as apheresis therapy can be invasive, time-consuming and expensive, while the number of centres providing such facilities is limited in some parts of the world.

Dr Patrick Moriarty, professor of the department of internal medicine at the University of Kansas Medical Center, said: "Findings from ODYSSEY ESCAPE suggest a role for Praluent in the overall management of patients with HeFH undergoing regular apheresis therapy, with the potential to reduce the need for burdensome apheresis treatments."

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