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New drug application for SGLT2, empagliflozin, submitted to FDA
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A new drug application for the novel investigational sodium glucose co-transporter-2 inhibitor, empagliflozin, has been submitted to the FDA, according to a press release.
Empagliflozin (Boehringer Ingelheim and Eli Lilly and Company) is similar to another SGLT2 inhibitor, canagliflozin (Invokana, Janssen), which was recommended for approval by the Endocrinologic and Metabolic Drugs Advisory Committee in January.
According to the press release, empagliflozin is being investigated in a phase 3 clinical trial program that plans to enroll more than 14,500 patients. Moreover, the program includes 12 multinational clinical trials, including a large cardiovascular outcomes trial. Presentation of the data is expected at scientific medical meetings and in publications this year and in 2014.
During the EASD annual meeting in October 2012, the pharmaceutical companies released results from a pooled analysis of phase 2b data for empagliflozin. Researchers collected data from two randomized, double blind, placebo-controlled trials that evaluated the safety and efficacy of empagliflozin alone (n=408) or as add-on therapy to metformin (n=495) in adults with type 2 diabetes.
According to data, 152 patients were assigned to empagliflozin 10 mg, 152 were assigned empagliflozin 25 mg and 153 were assigned placebo. After the 12-week study, mean systolic BP decreased by 3.8 mm Hg in the empagliflozin 10-mg group and by 4.5 mm Hg in the 25-mg group vs. 1.2 mm Hg in the placebo group.
Furthermore, empagliflozin was well tolerated, the researchers said. Adverse event rates were similar among treatment and placebo groups (34.2% and 31.6% in empagliflozin 10-mg and 25-mg groups, and 34.6% in the placebo group).
The most common adverse events associated with empagliflozin include urinary tract and genital infections.
For more information:
Hach T. #770. Presented at: the European Association for the Study of Diabetes 48th Annual Meeting; Oct. 1-5, 2012; Berlin.