Sanofi and Regeneron announce positive cholesterol data for Praluent (12/06/17 – 0.6 units)

Sanofi and Regeneron have announced new clinical trial data that demonstrates the effectiveness of Praluent in the treatment of diabetes patients with cholesterol problems.

The companies have shared the findings of two phase IIIb/IV studies from the ODYSSEY-DM programme, demonstrating the benefits offered by Praluent when administered on top of maximally tolerated doses of statins in people with diabetes and hypercholesterolaemia.

Praluent was shown to significantly reduce low-density lipoprotein cholesterol levels in the ODYSSEY DM-INSULIN study and demonstrated superiority to usual care in reducing non-high-density lipoprotein cholesterol in the ODYSSEY DM-DYSLIPIDEMIA study.

Both trials also found that a majority of patients reached their lipid goals with Praluent 75 mg every two weeks, with an overall safety profile comparable to the ODYSSEY phase III program.

Dr Lawrence Leiter, chair of the ODYSSEY DM steering committee, said: "The positive results from ODYSSEY DM-INSULIN provide valuable information on the efficacy and safety of Praluent in this high cardiovascular risk group."

Praluent is approved in more than 50 countries worldwide, including the US, EU, Japan, Canada, Switzerland, Mexico and Brazil.

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