Praluent gains EU approval as treatment of hypercholesterolemia

The European Commission has granted marketing authorization for Praluent (alirocumab) for the treatment of low-density lipoprotein (LDL) cholesterol, in certain adult patients with hypercholesterolemia. The drug was co-developed by US biotech firm Regeneron Pharmaceuticals (Nasdaq: REGN) and French pharma major Sanofi (Euronext: SAN).

Earlier this year, Praluent became the first US Food and Drug Administration-approved treatment in a new class of drugs known as PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors (The Pharma Letter July 26). However, it is second to be cleared in Europe, where Amgen’s (Nasdaq: AMGN) Repatha (evolocumab) beat it to clearance back in July for the same adult target group as well as in patients aged 12 years and older.

Aiming to differentiate its drug from Repatha, Sanofi pointed out that Praluent is the only EC-approved PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor that is available in two starting doses as a single 1-milliter (mL) injection (75mg and 150mg) once every two weeks, offering two levels of efficacy. Praluent will be available in a single-dose pre-filled pen that patients self-administer.