Novo Nordisk is expected to find out in October whether FDA will approve its long-acting insulin Tresiba for sale in the US market. However, if approved, Tresiba faces growing competition from Sanofi, which markets the leading basal insulin Lantus along with Toujeo.
While the FDA’s approval of alirocumab (Praluent injection) for high cholesterol is an important new treatment for patients with cardiovascular disease, health plan executives and others are worried about the drug’s price tag.
FDA’ s Endocrinologic and Metabolic Drugs Advisory Committee recommended this week to approve cholesterol-lowering drug evolocumab (Repatha) from Amgen in a 15-0 vote. It also voted 13-3 in favor of FDA approving Sanofi and Regeneron's Praluent (alirocumab), but most panel members called for a restricted label in high-risk patients with genetic conditions causing elevated cholesterol, rather than wider use in the general elevated cholesterol population.