The U.S. FDA has issued a complete response letter to Boehringer Ingelheim and Eli Lilly for the supplemental New Drug Application (sNDA) of the investigational medicine empagliflozin 2.5 mg as an adjunct to insulin for adults with type 1 diabetes.
According to the response letter, the agency is unable to approve the application in its current form, which is consistent with the outcome of the Endocrinologic and Metabolic Drugs Advisory Committee that voted 14-2 against the approval in November. The advisory committee cited lack of clinical data for the drug, which is already marketed as Jardiance for the treatment of type II diabetes. The briefing document prepared by the FDA for the panel members of the advisory committee in November noted that the "size of the database submitted to support safety of the 2. 5 mg dose is relatively small and of short duration."
"We remain committed to the continued study of therapies that may improve outcomes for adults with cardiorenal metabolic conditions, including diabetes," commented Mohamed Eid, M.D., M.P.H., M.H.A., vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim. In January 2011, the two drugmakers announced an alliance that centers on compounds representing several of the largest diabetes treatment classes.
Read the press release about the complete response letter
