FDA "Recommends"New Treatment for Type 2 Diabetes

Just caught this from the FDA Approval committee…


This is linked to a press release from the makers of the drug. Read into that however you’d like.

It’s worth noting that this is the recommendation from a committee…so the next step would be for the FDA to make the full approval.

The best paragraph (in my opinion) to sum it up:

“We are pleased by the Advisory Committee’s recommendation for approval of this investigational diabetes therapy,” said Elias Zerhouni, President, Global R&D, Sanofi. “By combining the complementary therapeutic effects of insulin glargine on fasting plasma glucose and of lixisenatide on postprandial plasma glucose, both of which can contribute to HbA1c lowering, this fixed-ratio product may address some of the unmet needs of adults living with type 2 diabetes who are considering initiating or intensifying insulin. We look forward to continuing to work with the FDA as it completes its reviews of these New Drug Applications.”

Thanks @mrmikelawson. What we haven’t heard is this backstory. I was at the FDA a the hearing on 5/24, this hearing was on 5/25. The GLP-1 drug lixisenatide was actually withdrawn by Sanofi in 2013 from being approved separately. Instead, Sanofi has sought for simultaneous approval of lixisenatide and a fixed single injection combination of lixisenatide and insulin glargine (Lantus). For whatever strategic reason they chose not to enter the market with lixisenatide alone.

This follows the approval by a vote of 16-0 the recommendation on 5.24 that the combination of Victoza/Tresiba in a single combination injection be approved. The vote of 14-2 for the simultaneous approval of lixisenatide and the combination of lixisenatide and Lantus while still positive was not as overwhelming as for the Victoza/Lantus. But still reflects overall strong support for both the new GLP-1 drug and the combination therapy.