Sanofi (NYSE:SNY) said today that the European Commission granted marketing authorization in Europe for its Suliqua combination product for adults with type II diabetes. The therapy is a fixed-ratio combination of basal insulin glargine and lixisenatide, intended to be used with metformin to improve patients’ glycemic control.
Suliqua will be available in 2 pre-filled SoloSTAR pens at different dosage levels to address the insulin needs of individual patients, Sanofi reported. The 10–40 pen will deliver 10-40 dose steps of insulin glargine at 100 Units/mL with 5-20 micrograms of lixisenatide. The 2nd pen will deliver 30-60 dose steps of insulin glargine in combination with 10-20 micrograms of lixisenatide.
“Suliqua is an innovative new combination therapy that has the potential to address significant unmet needs for people living with type II diabetes in Europe,” Sanofi’s president of global R&D Dr. Elias Zerhouni said in prepared remarks. “The approval of Suliqua represents the successful culmination of a concerted effort by Sanofi scientists to bring two injectable treatments together in a single and precisely titratable dose. Sanofi has a long history of elevating care for people with diabetes, and we believe Suliqua will make it easier for patients with inadequately controlled diabetes to reach their treatment goals.”
The regulatory approval was based on data from 2 phase III studies, LixiLan-O and LixiLan-L, Sanofi said, which evaluated the Suliqua therapy in more than 1,900 adults with type II diabetes. The studies showed that patients who took Suliqua achieved statistically superior blood sugar reductions compared to lixisenatide or insulin glargine alone.
“We welcome the addition of Suliqua in the EU to help address the needs of people living with type 2 diabetes who are currently not reaching their blood sugar targets,” Javier Ampudia Blasco, endocrinology & nutrition specialist at the Clinic University Hospital Valencia, added. “It is important to achieve glycemic control without increasing the risk of hypoglycemic events or additional weight gain when oral agents or basal insulin are no longer sufficient. The simple administration of this combination product of insulin and a glucagon-like peptide-1 receptor agonist in a single daily injection may help to reduce the daily complexity of diabetes management and improve efficacy for people with type 2 diabetes compared with its components. Suliqua is easy to use with dose adjustments based only in the fasting glucose values.”
The FDA approved Sanofi’s Suliqua in November 2016 and has been commercially available in the U.S. since earlier this month. Sanofi said it anticipates a European launch in the 2nd quarter this year.