EMA Committee Backs Approval of PCSK9 Inhibitor Alirocumab (Praluent)

Deborah Brauser


July 24, 2015

LONDON, UK – The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the proprotein convertase subtilisin kexin 9 (PCSK9) inhibitor alirocumab (Praluent, Sanofi) for individuals who cannot lower their high LDL-cholesterol levels with statins or who cannot tolerate statins[1].

The indications earmark the drug as an adjunct to diet in patients with both heterozygous familial and non–familial hypercholesterolemia or with mixed dyslipidemia.

After examining data on more than 3300 patients with alirocumab, the committee also noted that the drug's safety profile "is acceptable," with few serious treatment-related adverse events or discontinuations, according to its press release. However, "the effect . . . on cardiovascular morbidity and mortality has not yet been determined."

This CHMP approval recommendation follows its recommendation in May for PCSK9 competitor evolocumab (Repatha, Amgen), which was given full approval by the European Commission earlier this week.

Alirocumab is a monoclonal antibody given through biweekly subcutaneous injections. Today's thumbs-up from the CHMP will now be sent to the European Commission, which will make the final decision on whether this drug should be approved and made available within the European Union (EU).

On June 9, 2015, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) also gave its recommendation for approval of alirocumab. Full approval by the FDA is widely expected to come through soon.


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