Eli Lilly and Company announced that Glyxambi (empagliflozin/linagliptin) tablets are now available by prescription in many leading chain and independent pharmacies across the US, including Walgreens and Rite Aid.
Glyxambi, part of the Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company diabetes alliance portfolio, is the first and only dual inhibitor combination therapy approved in the US to combine the mechanisms of action of a sodium glucose co-transporter-2 (SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor in a once-daily tablet.
Glyxambi is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D) when both empagliflozin and linagliptin are appropriate treatments. Glyxambi is a once-daily tablet taken in the morning that combines 10 mg or 25 mg of empagliflozin, an SGLT2 inhibitor, with 5 mg of linagliptin, a DPP-4 inhibitor. Glyxambi is not for people with type 1 diabetes or for diabetic ketoacidosis (increased ketones in the blood or urine). If you have had pancreatitis (inflammation of the pancreas) it is not known if you have a higher chance of getting pancreatitis while taking Glyxambi.
"The rapid market availability of Glyxambi following its recent FDA approval in late January is a reflection of Boehringer Ingelheim and Lilly's commitment to bringing new treatment options to people with type 2 diabetes," said Kathleen Dowd, senior vice president, marketing, Boehringer Ingelheim Pharmaceuticals, Inc. "As the fourth diabetes medicine to emerge from our alliance pipeline in the US, we believe Glyxambi may help adults with type 2 diabetes lower their blood sugar and manage their diabetes."
Glyxambi should not be taken if you have severe kidney problems, are on dialysis or if you are allergic to empagliflozin and linagliptin or any of the ingredients in Glyxambi. Symptoms of a serious allergic reaction to Glyxambi may include skin rash, itching, flaking or peeling; raised red patches on your skin (hives); difficulty swallowing or breathing; or swelling of your face, lips, tongue, and throat that may cause difficulty breathing or swallowing. If you have any of these symptoms, stop taking Glyxambi and call your doctor or go to the emergency room right away.
"As an add-on to metformin, Glyxambi was superior in reducing A1C when compared with either empagliflozin or linagliptin alone," said David Kendall, M.D., vice president, medical affairs, Lilly Diabetes. "The management of type 2 diabetes requires a personalized treatment plan, and Glyxambi provides patients and their physicians with a new option to help improve blood sugar control."
The US Food and Drug Administration approval was based on a phase III clinical trial that evaluated the efficacy and safety of Glyxambi (10/5 mg and 25/5 mg) compared with the individual components of empagliflozin (10 mg or 25 mg) or linagliptin (5 mg) in adults with T2D who were also taking high-dose metformin (mean dose 1889 mg daily). The study, which randomized 686 adults with T2D and hemoglobin A1C (a measure of average blood glucose over the past two to three months) between 7.0 and 10.5 per cent, examined the change from baseline in A1C at 24 weeks. The study demonstrated superior A1C reduction with Glyxambi compared with the individual components of empagliflozin or linagliptin. Starting from a mean baseline of approximately 8.0 per cent, adults in this trial achieved a mean A1C of 6.9 and 6.7 percent with Glyxambi 10/5 mg and 25/5 mg, respectively, compared with a mean A1C of 7.3 and 7.4 per cent for empagliflozin 10 mg and 25 mg, respectively, and 7.3 per cent for linagliptin 5 mg.
Data recently published in Diabetes Care demonstrated that 58 per cent and 62 per cent of patients taking Glyxambi 10/5 mg or 25/5 mg, respectively, in addition to metformin achieved an A1C of less than 7 percent from a baseline A1C of approximately 8 per cent, compared with 28 per cent of patients taking empagliflozin 10 mg, 33 per cent taking empagliflozin 25 mg and 36 per cent taking linagliptin 5 mg.
Through 52 weeks, the safety profile of Glyxambi was demonstrated in a pooled analysis, and the most common adverse reactions were urinary tract infection (UTI) (12.5 percent and 11.4 per cent for Glyxambi 10/5 mg and 25/5 mg, respectively; through 52 weeks, no patient discontinued Glyxambi due to UTIs), nasopharyngitis (5.9 per cent and 6.6 per cent for Glyxambi 10/5 mg and 25/5 mg, respectively) and upper respiratory tract infection (7.0 per cent for Glyxambi 10/5 mg and 25/5 mg).
Serious side effects can happen to people taking Glyxambi, including inflammation of the pancreas (pancreatitis), which may be severe and lead to death. Before you start taking Glyxambi, tell your doctor if you have ever had pancreatitis, gallstones, a history of alcoholism, or high triglyceride levels. Stop taking Glyxambi and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centers on compounds representing several of the largest diabetes treatment classes. This alliance leverages the strengths of two of the world's leading pharmaceutical companies.