Glyxambi approval recommended by CHMP for adults with type 2 diabetes in the EU
Glyxambi is a single tablet that combines Jardiance and Trajenta and has been shown to improve blood sugar control in adults with type 2 diabetes.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Glyxambi (empagliflozin/linagliptin) for use in adults with type 2 diabetes (T2D). Glyxambi, from the Boehringer Ingelheim and Eli Lilly and Company Diabetes Alliance, is a single tablet combining Jardiance (empagliflozin), a sodium glucose co-transporter-2 (SGLT2) inhibitor, and Trajenta (linagliptin), a dipeptidyl peptidase-4 (DPP-4) inhibitor.
This recommendation is based on data from three Phase III clinical trials evaluating the efficacy and safety of Glyxambi in patients with T2D. The CHMP positive opinion recommends Glyxambi, fixed dose combination of Jardiance and Trajenta, for use in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control when metformin and/or sulphonylurea and one of the monocomponents of Glyxambi do not provide adequate glycaemic control, or when a patient is already being treated with the free combination of Jardiance and Trajenta.
“Half of people with type 2 diabetes do not achieve recommended blood sugar targets, so new treatment options are still needed,” said Professor Hans-Juergen Woerle, Global Vice President Medicine, Therapeutic Area Metabolism, Boehringer Ingelheim. “We are excited about the positive opinion for Glyxambi from the CHMP. We believe that this treatment for type 2 diabetes will provide physicians and patients in Europe with another valuable option to improve blood sugar control.”
Boehringer Ingelheim and Lilly expect to receive final marketing authorisation from the European Commission in the coming months.
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