16. Adlyxin

Sanofi sign

Active ingredient: lixisenatide
Disease: diabetes
Peak sales estimate: $173 million in 2022
Approved: July 27
Company: Sanofi

The Scoop: Sanofi’s Adlyxin is very tardy to the GLP-1 class in the U.S., thanks to a bar-raising at the FDA for diabetes drugs a few years ago. Seeing the writing on the wall, the French drugmaker pulled its approval application pending a cardiovascular safety trial, which finally reported out clean last year. After those years of delay, Adlyxin came to market as Novo Nordisk’s dominant daily med Victoza was duking it out with Eli Lilly’s weekly Trulicity for most of the GLP-1 market share, with entries from AstraZeneca (daily Bydureon, weekly Byetta) and GlaxoSmithKline (Tanzeum) fighting over the rest. Payer pressure on the class gives Sanofi a chance to score scripts, however, by trading discounts for favorable formulary coverage. And Sanofi is hoping momentum in ex-U.S. markets, some favorable head-to-head data, and newly approved lixisenatide/Lantus combo, Soliqua, can put the franchise on a steady upward course. -- Tracy Staton

16. Adlyxin

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