On 18 December 2025, the European Commission withdrew the marketing authorisation for Lyxumia (lixisenatide) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Sanofi Winthrop Industrie, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. Lyxumia was granted marketing authorisation in the EU on 1 February 2013 for treatment of type 2 diabetes. The marketing authorisation was initially valid for a 5\-year period. It was then granted unlimited validity on 18 September 2017\. Lyxumia is GLP\-1 receptor agonist. There are therapeutic alternatives such as other GLP\-1 receptor agonists authorised and available throughout the EU for the treatment of type 2 diabetes.
Therapeutic Indication
Lyxumia is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control.
Therapeutic Area (MeSH)
ATC Code
A10BJ03
ATC Item
N/A
Pharmacotherapeutic Group
N/A
Active Substance (Summary)
INN / Common Names
EMA Name
Lyxumia
Medicine Name
Lyxumia
Aliases
N/ANo risk management plan link.
