FDA approves Sanofi's Admelog for diabetes

Sanofi (Euronext:SAN; NYSE:SNY) said FDA approved an NDA for Admelog insulin lispro injection to improve blood sugar control in adults with Type II diabetes and in patients three years and older with Type I diabetes. The company said it is the first FDA approval for a follow-on mealtime insulin.

Sanofi told BioCentury it will disclose pricing details upon launch of Admelog in early 2018. The company submitted the NDA under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products...