The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) gave qualified support Wednesday for Sanofi SA’s fixed-ratio combination diabetes product, voting 12-2 to recommend approval. (One panelist had to leave before the vote.)
While the panelists agreed that the insulin glargine (Lantus)/lixisenatide combo demonstrated safety and efficacy in type 2 diabetes, several expressed concerns about the Solostar pen devices used to deliver the once-daily injection. Those concerns resulted in the no votes and a number of qualified yes votes.
The Paris-based drug company has proposed making the combo available via two Solostar pen devices. One