FDA approves Sanofi's Adlyxin for adult type 2 diabetes patients

The US Food and Drug Administration approved Adlyxin (lixisenatide), a once-daily mealtime GLP-1 receptor agonist injection indicated as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes.

The drug, from French pharma major Sanofi (Euronext: SAN), is already approved under the trade name Lyxumia in more than 60 countries, and launched in around 40 markets. Adlyxin was in-licensed from Denmark’s Zealand Pharma (OMX Copenhagen: ZEAL), with the FDA approval triggering a $5 million milestone for the company, which is also eligible to receive remaining milestone payments of up to $135 million as well as royalties on global sales.

"The approval of Adlyxin reaffirms our continued commitment to addressing the challenges faced by people living with diabetes when trying to reach and maintain their individual blood glucose (HbA1c) targets,"said Peter Guenter, executive vice president, head, Global Diabetes & Cardiovascular Business Unit, Sanofi.