FDA Gives Nod to Sanofi’s Diabetes Drug Adlyxin

The FDA has approved Sanofi’s Adlyxin for use in Type 2 diabetes patients in conjunction with diet and exercise.

The approval was based on 10 clinical trials in which the treatment was evaluated both as a standalone therapy and for use in conjunction with other diabetes drugs: metformin, sulfonylureas, pioglitazone and basal insulin. Data show the candidate met its primary endpoint of improving blood sugar levels in patients.

The agency has requested that the company conduct postmarketing trials to evaluate its dosing, efficacy and safety in pediatric patients, along with a study on its immunogenicity.