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.”