Sanofi-Aventis' Suliqua has been approved in the European Union expanding treatment options for people with type II diabetes.
The therapy is a fixed-ratio combination of insulin glargine, a basal insulin analogue, and lixisenatide, a glucagon-like peptide 1 (GLP-1) receptor agonist. Insulin glargine binds specifically to the human insulin receptor while lixisenatide acts via enhancing glucose-dependent insulin secretion and reducing glucagon release.
Suliqua has been authorised for use in combination with metformin to improve glycaemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin.
The approval rides on the back of data from two Phase III studies, LixiLan-O and LixiLan-L, which enrolled more than 1,900 adults with type II diabetes worldwide to assess the efficacy and safety of the fixed-ratio combination when used in patient populations insufficiently controlled after OADs and after basal insulin therapy, respectively.
According to the data, Suliqua demonstrated statistically superior blood sugar (HbA1c) reduction versus lixisenatide (-0.8 percent) and insulin glargine 100 Units/mL (-0.3 percent) in LixiLan-O, and versus insulin glargine 100 Units/mL (-0.5 percent) in LixiLan-L.
Elias Zerhouni, president of Global R&D at Sanofi, said 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".
"We believe Suliqua will make it easier for patients with inadequately controlled diabetes to reach their treatment goals."
The approval has triggered a $10 million payment to Danish drugmaker Zealand Pharma as per the terms of a license agreement between the two firms for lixisenatide. Zealand is also eligible to receive remaining milestone payments of up to $100 million as well as low double-digit percentages on global sales in royalty income.