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Home Industry News Sanofi and Regeneron receive EU approval for cholesterol therapy Praluent

Sanofi and Regeneron receive EU approval for cholesterol therapy Praluent

28th September 2015

Sanofi and Regeneron have announced that their new cholesterol therapy Praluent has been approved by the European Commission.

The therapy has been approved for the treatment of bad cholesterol, known as low-density lipoprotein (LDL) cholesterol, in certain adult patients with hypercholesterolaemia.

It is the only EU-approved PCSK9 inhibitor that is available in two starting doses as a single 1-millitre injection once every two weeks, offering two levels of efficacy. It will be available in a single-dose prefilled pen that patients can self-administer.

In phase III trials, the majority of patients who started on the lower Praluent dose were able to achieve their predefined LDL cholesterol goals, and maintained treatment at this dose throughout the assessment period.

Dr Olivier Brandicourt, chief executive officer of Sanofi, said: "Our clinical programme focused on patients with the highest unmet needs, most of whom were on maximally-tolerated statins and/or other lipid-lowering therapies."

The study programme for Praluent assessed the largest group of heterozygous familial hypercholesterolaemia patients ever studied in a phase III programme.ADNFCR-8000103-ID-801801575-ADNFCR

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