EU approval for Sanofi’s type 2 diabetes treatment
Posted: 19 January 2017 | | No comments yet
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
The European Commission (EC) has granted marketing authorisation in Europe for Sanofi‘s Suliqua, a titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes.
Suliqua is 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.
“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, Sanofi.
“The approval represents the successful effort by Sanofi scientists to bring two injectable treatments together in a single and precisely titratable dose.
We believe Suliqua will make it easier for patients with inadequately controlled diabetes to reach their treatment goals.”
The decision to grant marketing authorisation in Europe for Suliqua was based on data from two Phase 3 studies, LixiLan-O and LixiLan-L, which enrolled more than 1,900 adults with type 2 diabetes worldwide to evaluate the efficacy and safety of the fixed-ratio combination when used in patient populations insufficiently controlled after OADs and after basal insulin therapy, respectively.
Suliqua demonstrated statistically superior blood sugar (HbA1c) reduction versus lixisenatide (-0.8%, p<0.0001) and insulin glargine 100 Units/mL (-0.3%, p<0.0001) in LixiLan-O, and versus insulin glargine 100 Units/mL (-0.5%, p<0.0001) in LixiLan-L.2,3
The treatment will be delivered in two pre-filled pens, providing different dosing options that may help answer individual market and patient insulin needs. The differentiation between the pen strengths is based on the dose range and ratios of each pen.
Marketing authorisation in Europe for Suliqua is applicable to the 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway, and follows the November 2016 positive opinion issued by the CHMP of the EMA.
The product was approved by FDA in November 2016, as Soliqua 100/33, and has been available in the US since January 2017. Launches in individual EU countries are imminently anticipated.