- At the FDA's request, Sanofi (SNY -0.7%) submits additional information to the agency pertaining to the pen delivery device for its investigational once-daily fixed-dose combination of basal insulin glargine 100 Units/ml and GLP-1 receptor agonist lixisenatide, branded as iGlarLixi, for the treatment of adults with type 2 diabetes. The action constitutes a major amendment to the New Drug Application (NDA) so the FDA's action date (PDUFA) is automatically extended three months to November.
- On May 25, the FDA's Advisory Committee voted 12 - 2 backing approval.
- Read now Sanofi Should Be Thinking Longer Duration In GLP-1s