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Sanofi gains FDA approval for Toujeo once-daily basal insulin

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The FDA late Wednesday approved a once-daily, long-acting basal insulin with recombinant DNA technology to improve glycemic control in adults with type 1 or type 2 diabetes, according to a news release from the company.

The insulin glargine 300 U/mL injection (Toujeo rDNA, Sanofi), given the go-ahead by the agency based on results from the EDITION clinical trial program, is expected to be available within the first quarter of 2015.

“Nearly 50 percent of people living with diabetes remain uncontrolled,” John Anderson, MD, past president of the American Diabetes Association, of the Frist Clinic of Nashville, Tennessee, said in the release. “Despite the proven efficacy of insulin, ensuring effective titration and maintenance can be a challenge for both patients and healthcare professionals due to hypoglycemia concerns. Toujeo provides a new option that may help patients manage their diabetes.”

Within the EDITION clinical trial program, researchers conducted a series of international phase 3 studies evaluating the efficacy and safety of the therapy in more than 3,500 adults with type 1 and type 2 diabetes.

In open-label, randomized, active-control, parallel, treat-to-target studies, with durations up to 26 weeks and including 6 months safety extension, investigators compared the insulin glargine injection 300 U/mL against once-daily insulin glargine injection 100 U/mL (Lantus rDNA, Sanofi).

Insulin glargine 300 U/mL met the primary study endpoints in all studies, demonstrating blood glucose control similar to insulin glargine 100 U/mL, according to the release.

Nasopharyngitis was reported by 12.8% of patients with type 1 and 7.1% with type 2, and upper respiratory tract infection was reported by 9.5% and 5.7%, respectively. These were the most common adverse events, with the exception of hypoglycemia.

Rates of severe and documented symptomatic hypoglycemia are listed on the drug label, along with pharmacokinetic/pharmacodynamic information, according to the release.

The insulin glargine 300 U/mL will be available in the SoloSTAR prefilled disposable pen, containing 450 units of the therapy; one-third of the injection volume is required to deliver the same number of units compared with insulin glargine 100 U/mL.