The New Drug Application (NDA) for the fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide was for the treatment as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The 15-member panel voted 12 to 2, as 1 panelist did not vote because of travel, to approve the combination.
Elias Zerhouni, President, Global R&D, Sanofi, said:
“We are happy by the Advisory Committee’s recommendation for approval of this investigational diabetes therapy. 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.”
Advisory committee recommendations are not binding, but the FDA does take the panel’s recommendations into consideration when it decides whether to approve the drug.
Sanofi is in high stakes competition for the diabetes market with Novo Nordisk, whose similar combination received unanimous support from the panel on Tuesday, as the companies race to be the first to introduce such a combination treatment to the U.S. market.
Novo Nordisk’s formulation, based on two separate treatments approved in the U.S., is currently approved and marketed in Europe under the Xultophy brand. It fuses the long-acting insulin Tresiba with Victoza, which also mimics GLP-1.
If and when the combination drugs are approved, patients could get both treatments in a once-daily shot, rather than needing two injections.