Sanofi’s Suliqua recommended by CHMP for European approval

Sanofi has announced that its type 2 diabetes therapy Suliqua has been recommended for European regulatory approval.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion on the marketing authorisation of the once-daily therapy, which combines basal insulin glargine with the GLP-1 receptor agonist lixisenatide.

Suliqua has been endorsed for use in combination with metformin for the treatment of adults with type 2 diabetes to help improve glycaemic control when this has not been achieved using metformin.

This positive opinion is based on data from two phase III studies, LixiLan-O and LixiLan–L, which enrolled more than 1,900 adults with type 2 diabetes worldwide and highlighted the blood glucose control benefit associated with the drug.

Once approved, Suliqua will be made available in two pre-filled SoloSTAR pens, providing different dosing options to address market and patient needs.

Dr Elias Zerhouni, president of global research and development at Sanofi, said: "We welcome the CHMP positive opinion for Suliqua and look forward to the final decision of the European Commission, as well as the upcoming US Food and Drug Administration decision."

With over 20 years of experience within the pharmaceutical market, we at Zenopa have the knowledge, skills and expertise to help find the right job for you. To find out more about the current pharmaceutical roles we have available, you can search for the latest job roles, register your details, or contact the team today.