Glyxambi® (empagliflozin/linagliptin) approval recommended by CHMP for adults with type 2 diabetes in the European Union
INGELHEIM, Germany & INDIANAPOLIS, Indiana–(BUSINESS WIRE)– The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) today 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.
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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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About the Phase III Clinical Trials
The CHMP positive opinion is based on clinical data from three Phase III clinical trials.
- Following a run-in period, two 24 week trials with adult T2D patients on metformin studied:
- Jardiance ® added to Trajenta ® versus placebo added to Trajenta ®
- Trajenta ® added to Jardiance ® versus placebo added to Jardiance ®*
- The trials showed statistically significant reductions in blood sugar levels when Jardiance ® was added to patients on Trajenta ® and metformin, and when Trajenta ® was added to patients on Jardiance ® and metformin, compared to adding placebo.
- An additional factorial design study, which also investigated Jardiance ® and Trajenta ® combined added to metformin, was conducted for 52 weeks. This trial showed that the combination of Jardiance ® and Trajenta ® added to metformin resulted in clinically and statistically significant reductions in blood sugar levels in comparison to patients treated with Jardiance ® or Trajenta ® alone when added to metformin.
The safety profile of the combination in these trials was comparable to the safety profiles of the monocomponents.
* This study was analysed as two separate studies according to the dose of empagliflozin as 10 mg or 25 mg, respectively.
About Glyxambi ®
Glyxambi ® is a single tablet combining Jardiance ® and Trajenta ®. 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 ®.
About Diabetes
More than 415 million people worldwide have diabetes, of which 193 million are estimated to be undiagnosed. By 2040, the number of people with diabetes is expected to rise to 642 million people worldwide. T2D is the most common form of diabetes, responsible for up to 91 percent of diabetes cases in high-income countries. Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.
Intended audiences
This press release is issued from Boehringer Ingelheim Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where Boehringer Ingelheim and Eli Lilly and Company do business.
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Please click on the link below for ‘Notes to Editors’ and ‘References’:
http://www.boehringer-ingelheim.com/press-release/T2D-Glyxambi-EU-approval-recommended-by-CHMP
View source version on businesswire.com: http://www.businesswire.com/news/home/20160916005462/en/
Contacts
Boehringer Ingelheim GmbH
Dr Petra Kienle
Product Communication Manager
Email: petra.kienle@boehringer-inge lheim.com
Phone: +49 6132 77 143877
or
Lilly Diabetes
Molly McCully
Communications Manager
Email: mccully_molly@lilly.com
Phone: +1 317 478 5423