Suliqua receives marketing authorization in the EU shortly after the product was approved in the United States as Soliqua.
Sanofi recently announced that the European Commission awarded marketing authorization of Suliqua, a once-daily treatment for adults with type 2 diabetes. Suliqua is a titratable, fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor antagonist lixisenatide.
The injection is indicated in combination with metformin in patients who did not achieve glycemic control with metformin monotherapy, or in a combination of metformin and an oral glucose-lowering drug or basal insulin, according to a press release from Sanofi.
“Suliqua is an innovative new combination therapy that has the potential to address significant unmet needs for people living with type 2 diabetes in Europe,” said Elias Zerhouni, MD, president, Global R&D at Sanofi. “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.”
Suliqua received marketing authorization based on positive findings from two phase 3 clinical trials, LixiLan-O and LixiLan-L. These trials included more than 1900 patients with type 2 diabetes, and assessed the efficacy and safety of Suliqua.
The investigators discovered that treatment with Suliqua resulted in significantly higher HbA1c reduction compared with lixisenatide and insulin glargine 100 Units/mL in LiliLan-O. In LixiLan-L, Suliqua outperformed insulin glargine 100 Units/mL, according to the press release.
Suliqua will be marketed as 2 pre-filled SoloSTAR pens that will be sold in varying doses depending on the needs of the specific patient. For example, Sanofi reported that the 10-40 SoloSTAR prefilled pen will deliver 10 to 40 dose steps of insulin glargine 100 Units/mL in combination with 5 to 20 micrograms of lixisenatide.
The marketing authorization includes the 28 member states of the European Union, Iceland, Liechtenstein, and Norway. This authorization follows a positive opinion issued by the Committee for Medicinal Products for Human Use.
The product was approved by the FDA as Soliqua 100/33, and has been available for use in the United State since early January 2017, according to Sanofi.
“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,” said Dr Javier Ampudia Blasco, Specialist of Endocrinology and Nutrition at the Clinic University Hospital Valencia. “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.”