The European Commission has granted marketing authorization for Sanofi’s and Regeneron Pharmaceuticals, Inc.’s for Praluent (alirocumab) for the treatment of bad cholesterol, known as low-density lipoprotein (LDL) cholesterol, in certain adult patients with hypercholesterolemia. Praluent is an PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor that is available in two starting doses as a single 1-milliter (mL) injection (75 mg and 150 mg) once every two weeks, offering two levels of efficacy. Praluent will be available in a single-dose pre-filled pen that patients self-administer.

Praluent, which is also approved in the US, is pegged as a potential blockbuster for Sanofi and Regeneron, which are competing against another recently approved PCSK9 inhibitor, Amgen’s Repatha (evolocumab). Based on estimates for 2019 sales, a recent Thomson Reuters analysis puts potential revenues at Regeneron Pharmaceuticals and Sanofi's Praluent (alirocumab) at $4.4 billion, and Amgen's’ evolocumab at nearly $1.9 billion by 2019. Praluent received FDA approval in July, and the drug is under regulatory review in the European Union (EU) for which a decision is expected for late September. Repatha is approved in both the EU and the US.

Source: Sanofi