FDA approval of Lilly / bringer diabetes compound drug glyxambi

Source: dxy-2015-02-05 FDA approved Lilly and glixambi (empagliflozin / linagliptin) as an adjuvant treatment drug, combined with diet and exercise to improve the blood glucose control of type 2 diabetes patients, as reported by the two companies Lilly points out that glyxambi is the first and only diabetes treatment drug in the United States that combines an SGLT2 inhibitor with a DPP-4 inhibitor in one tablet This compound drug is taken once a day and in the morning "Half of patients with type 2 diabetes fail to achieve the recommended level of blood glucose control, which makes new treatment options more important than ever," commented Mason, vice president of the U.S diabetes business of Lilly, adding, "glyxambi's approval provides a new type of prescription drug for U.S doctors and patients to manage the disease." The treatment was approved in two sizes, 10 mg or 25 mg of empagliflozin, an SGLT2 inhibitor, and 5 mg of linagliptin, an DPP-4 inhibitor Glyxambi was developed by the diabetes alliance established by Lilly and bringer Ingelheim The two alliance agreements were modified in some markets last October Linagliptin was approved by FDA in 2011 under the trade name tradjenta for type 2 diabetes, while empagliflozin was approved by FDA last year under the trade name jardiance The approval was based on data from a phase 3 trial that evaluated the efficacy and safety of glyxambi and its individual components in 686 adults with type 2 diabetes who were also taking metformin The results showed that after 24 weeks of treatment, there was a statistically significant difference in A1C reduction between compound drugs and empagliflozin and linagliptin alone In addition, a larger proportion of patients treated with glyxambi had HbA1c levels below 7% compared with any single drug