Having been approved for lixisenatide in Europe earlier this month, Sanofi is now focusing on getting the thumbs-up for the diabetes drug in the USA.
The French drugmaker has announced that the US Food and Drug Administration has accepted for review a New Drug Application for lixisenatide, the first once-daily prandial GLP-1 receptor agonist for the treatment of adults with type 2 diabetes. The filing follows approval of the drug, where it will be marketed as Lyxumia, in the European Union at the beginning of February.
The NDA is based on results from the GetGoal programme, which showed that lixisenatide, co-developed with Zealand Pharma, demonstrated significant reductions in HbA1c and a beneficial effect on body weight, plus a limited risk of hypoglycaemia. The programme, included 11 clinical trials involving more than 5,000 patients.
Sanofi added that available data from the ongoing Elixa trial, a cardiovascular outcome study of lixisenatide in patients who recently experienced an acute coronary event were also submitted, as required by the FDA.