Sanofi has received a recommendation for European approval of once-daily Lyxumia for the treatment of adults with type 2 diabetes mellitus.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has endorsed the therapy to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin, in cases when these, together with diet and exercise, have proven ineffective on their own.
“Sanofi has received a CHMP recommendation for approval of Lyxumia as a once-daily treatment for type 2 diabetes mellitus.“
Data from the GetGoal phase III programme has demonstrated the efficacy, safety and tolerability profile of the drug among more than 5,000 test subjects.
Sanofi now expects to receive final European approval of lixisenatide within two or three months, while a US regulatory submission is also planned next month.
Pierre Chancel, senior vice-president for global diabetes at Sanofi, said: "The CHMP positive opinion for Lyxumia marks an important milestone in the development of this compound and brings us one step closer to serving even more patients by expanding the Sanofi diabetes product portfolio."
This comes after the firm recently announced the appointment of Dr Gary Nabel as its new chief scientific officer, joining the company from the US National Institutes of Health.