The FDA on Friday approved Boehringer Ingelheim and Eli Lilly's Jardiance (empagliflozin) as an addition to diet and exercise to improve glycaemic control in adults with type 2 diabetes. The FDA had previously declined to approve the SGLT2 inhibitor, citing issues at one of the company’s manufacturing plant in Ingelheim, Germany, but Boehringer Ingelheim confirmed in June that the issue has since been resolved.
The FDA noted that the approval of Jardiance was supported by data from seven clinical trials involving a total of 4480 patients with type 2 diabetes. Results reported in January 2013 suggest that Jardiance was associated with a significant change in HbA1c versus placebo when used both as monotherapy and in combination with other treatments.
The agency said that a number of post-marketing trials will be required of Jardiance, including the completion of an ongoing cardiovascular outcomes trial, as well as safety and efficacy and pharmacokinetic/pharmacodynamic studies in children. The regulator is also requiring the companies to conduct an animal juvenile toxicity study focusing on renal development, bone development and growth.
Jardiance was co-developed by Boehringer Ingelheim and Eli Lilly under a 2011 agreement focusing on four experimental compounds. The therapy was cleared by European regulators for the treatment of type 2 diabetes in May.
For related analysis, see ViewPoints: Is the SGLT-2 inhibitor class of diabetes treatments still undervalued?
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