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Home Industry News Sanofi and Regeneron report positive Praluent data at ESC 2015

Sanofi and Regeneron report positive Praluent data at ESC 2015

3rd September 2015

Sanofi and Regeneron have reported positive phase III clinical trial data for their drug Praluent at the recent European Society of Cardiology (ESC) Congress.

A new analysis of heterozygous familial hypercholesterolaemia (HeFH) patients included in the Odyssey clinical trial programme showed that Praluent was able to significantly reduce levels of bad cholesterol, known as low-density lipoprotein cholesterol (LDL-C).

At week 24, when the primary efficacy endpoint was assessed, patients treated with Praluent had an average 56 percent greater reduction in LDL-C compared to placebo, with reductions observed as early as week four and maintained for the duration of therapy until week 78.

This analysis included 1,257 HeFH patients, which represents the largest group of HeFH patients ever studied in a phase III programme.

Dr John Kastelein, a professor of medicine at the University of Amsterdam, said: "Both Praluent 75 mg and 150 mg significantly reduced LDL-C levels below 100 mg/dL and sustained these lower levels through 78 weeks, offering patients and their doctors a flexible approach to treatment."

The drug was recommended for European regulatory approval by the Committee for Medicinal Products for Human Use in July.ADNFCR-8000103-ID-801799471-ADNFCR

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