FDA gives PCSK9 inhibitor priority review

The FDA granted priority review status to alirocumab, a monoclonal antibody designed to reduce low-density lipoprotein (LDL) cholesterol in statin-intolerant patients.

Regeneron Pharmaceuticals and Sanofi announced the FDA's decision, which puts the target action date at July 24. Alirocumab (Praluent) inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9) and is intended as a treatment of patients with hypercholesterolemia.

Safety and efficacy results from ODYSSEY ALTERNATIVE were presented at the 2014 meeting of the American Heart Association. The trial was an international, randomized, double-blind, double-dummy placebo-controlled study. It enrolled patients who were very high-, high- or moderate-risk who had a history of statin intolerance, which was defined as the inability to tolerate at least two different statins because of skeletal-muscle symptoms, with one of the statins at the lowest approved starting dose.

At 24 weeks, the alirocumab group had a 45 percent reduction in LDL cholesterol. Fewer patients in the alirocumab group reported skeletal-muscle-related treatment-emergent adverse events than in the other groups.