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FDA approves expanded indication for combination insulin, GLP-1 injectable

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The FDA on Wednesday approved an expanded label indication for a fixed-ratio combination of insulin glargine and lixisenatide for the treatment of patients with type 2 diabetes that is poorly controlled with oral antidiabetes therapy, Sanofi announced in a press release.

The once-daily injection (Soliqua), a fixed combination of 100 U/mL insulin glargine (Lantus) and 33 µg/mL of the GLP-1 receptor agonist lixisenatide (Adlyxin), was previously approved for use as an add-on to diet and exercise for patients with type 2 diabetes that is uncontrolled with long-acting insulin or lixisenatide.

“Many people living with type 2 diabetes are uncontrolled on diet and exercise alone and could require additional interventions to help lower their blood sugar levels,” Michelle Carnahan, North America head of primary care for Sanofi, said in the release. “This FDA decision marks the first combination insulin and GLP-1 injectable medicine approved for adults living with type 2 diabetes who are uncontrolled with diet and exercise, potentially providing them access to an option that can help them achieve their treatment goals.”

The FDA approval was based on data from the LixiLan-O clinical trial, in which researchers assigned participants with type 2 diabetes uncontrolled with oral antidiabetes therapies to the combination therapy, basal insulin glargine or lixisenatide for 30 weeks.

Treatment with Soliqua 100/33 led to greater reductions in blood glucose levels vs. insulin glargine and lixisenatide, with mean reductions of –1.6% for Soliqua, –1.3% for insulin glargine and –0.9% for lixisenatide (P < .0001), the researchers reported. More patients also reached target blood glucose levels with Soliqua 100/33 (74%) vs. participants assigned insulin glargine (59%) or lixisenatide (33%).

The most frequently reported adverse events with the combination drug included hypoglycemia, as well as nausea (10%), nasopharyngitis (7%), diarrhea (7%) and upper respiratory tract infection (5%).

Sanofi is also continuing to offer a support program called Soliqua 100/33 COACH, which is free to adults with type 2 diabetes being prescribed Soliqua 100/33. – by Regina Schaffer

Disclosure: Carnahan reports she is North America head of primary care for Sanofi.