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Ute E. Schmidt
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Upon approval, new treatment will provide a single tablet option for adults who need to improve their blood sugar control
For Non-U.S. and Non-UK Media
Ingelheim, Germany, 25 May, 2012 – Boehringer Ingelheim and Eli Lilly and Company today announced that they have received a positive opinion from the European Medicines Agency's (EMA) medicinal committee recommending approval of Jentadueto™, which combines the DPP-4 inhibitor, linagliptin (the active ingredient in Trajenta® tablets) and metformin in a single tablet.1 If approved by the European Commission, linagliptin/metformin hydrochloride (HCl) will provide a new, single-tablet treatment option, taken twice-daily, for adults with Type 2 Diabetes who need to improve control of their blood glucose.1 In clinical studies, linagliptin/metformin HCl demonstrated benefit to patients by offering another dosing option with effective glycaemic control and a favourable side effect profile.
The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of linagliptin/metformin hydrochloride (HCl) for use alongside diet and exercise to improve glycaemic control in adults with Type 2 Diabetes who are inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of linagliptin and metformin. In clinical trials, statistically significant, placebo-corrected mean reductions in haemoglobin A1c (HbA1c or A1C) levels of -1.7 percent were observed in patients with inadequate glycaemic control when the maximum dose of 2.5 mg linagliptin/1,000 mg metformin HCI was administered twice daily.1 HbA1c is measured in people with diabetes to provide an index of blood glucose control for the previous two to three months. In clinical studies, linagliptin/metformin HCl did not cause any significant change in body weight, and can be used alone or in combination with a sulphonylurea, a commonly prescribed medication for Type 2 Diabetes.
"The CHMP positive opinion for Jentadueto™ marks another important regulatory milestone for the Boehringer Ingelheim and Eli Lilly and Company worldwide diabetes alliance," said Prof. Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "Across Europe many people with Type 2 Diabetes require more than one treatment to adequately manage their diabetes. As a single-tablet treatment, we believe that Jentadueto™ will help patients with Type 2 Diabetes achieve and maintain glycaemic control and improve overall wellbeing."
Linagliptin/Metformin HCl Clinical Trials
In a 24-week, randomised, double-blind, placebo controlled study evaluating 791 patients with Type 2 Diabetes and inadequate glycaemic control with diet and exercise, 2.5 mg linagliptin/1,000 mg metformin HCl twice daily demonstrated the following:1
The recommendation for approval of linagliptin/metformin HCl tablets was based on clinical trials that evaluated linagliptin and metformin as separate tablets. Bioequivalence of linagliptin/metformin HCl was demonstrated with co-administered linagliptin and metformin tablets in healthy subjects with Type 2 Diabetes.1,2
In clinical studies, adverse reactions were uncommon. Gastrointestinal disorders occurred most frequently during initiation therapy with linagliptin/metformin HCl or metformin HCl and tended to resolve spontaneously. A comparable rate of diarrhoea was reported with linagliptin/metformin HCl treatment versus metformin plus placebo (0.9 percent and 1.2 per cent respectively). Due to the impact of background therapy, hypoglycaemia was more commonly reported in patients treated with the combination of linagliptin/metformin HCl and sulphonylurea compared with those treated with the combination of placebo, metformin and sulphonylurea (22.9 percent versus 14.8 percent, respectively).1
Linagliptin (5 mg, once-daily) is marketed as Trajenta® across Europe and Canada, as Tradjenta® in the US, and Trazenta® in Japan, as well as in additional markets.
About Linagliptin/Metformin HCl
Linagliptin/metformin HCl is not intended to be used in patients with Type 1 Diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine).1,2
The use of linagliptin/metformin HCl in combination with insulin has not been adequately studied.1,2
Subject to approval, linagliptin/metformin HCl is expected to be available in the following twice-daily doses in Europe: 2.5 mg linagliptin/850 mg metformin tablets and 2.5 mg linagliptin/1,000 mg metformin tablets.1
Linagliptin is an inhibitor of the enzyme DPP-4 (dipeptidyl peptidase-4) which is involved in the inactivation of the incretin hormones GLP-1 and GIP (glucagon-like peptide-1, glucose-dependent insulinotropic polypeptide). Linagliptin glucose-dependently increases insulin secretion and lowers glucagon secretion thus resulting in an overall improvement in the glucose homoeostasis.1
Linagliptin (5 mg, once-daily) is marketed as Trajenta® across Europe and Canada, as Tradjenta® in the US, and Trazenta® in Japan, as well as in additional markets.3,4
Linagliptin is a prescription medicine that is used along with diet and exercise to lower blood glucose in adults with Type 2 Diabetes.3,4 Linagliptin is not for people with Type 1 Diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).3,4 It is not known if linagliptin is safe and effective when used with insulin.4
An estimated 366 million people worldwide have diabetes.5 Type 2 Diabetes is the most common type, accounting for an estimated 90 percent of all diabetes cases.5 Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.6
Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centres on four pipeline compounds representing several of the largest treatment classes. This alliance leverages the companies' strengths as two of the world's leading pharmaceutical companies, combining Boehringer Ingelheim's solid track record of research-driven innovation and Lilly's innovative research, experience, and pioneering history in diabetes. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs. Find out more about the alliance at www.boehringer-ingelheim.com or www.lilly.com.
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 44,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.
As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.
In 2011, Boehringer Ingelheim achieved net sales of about 13.2 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, IN, Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.
About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world’s first commercial insulin. Today we work to meet the diverse needs of people with diabetes through research and collaboration, a broad and growing product portfolio and a continued commitment to providing real solutions – from medicines to support programs and more – to make lives better.
For more information, visit www.lillydiabetes.com.
This press release contains forward-looking statements about linagliptin and linagliptin/metformin HCl tablets for the treatment of Type 2 Diabetes. It reflects Lilly's current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that linagliptin and linagliptin/metformin HCl will be commercially successful. For further discussion of these and other risks and uncertainties, please see Lilly's latest Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
1Boehringer Ingelheim. Data on File.
2Jentadueto™ (linagliptin/metformin HCI) tablets. Highlights of Prescribing Information. Initial US Approval: 2012
3Trajenta™ (linagliptin) tablets. EMA Summary of Product Characteristics. Approval 25 September 2011. www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002110/WC500115745.pdf
4Tradjenta™ (linagliptin) tablets. Highlights of Prescribing Information. Initial U.S. Approval: 2011.
5International Diabetes Federation. Diabetes Atlas 5th edn. www.idf.org, 2010.
6World Health Organization: Fact Sheet No. 312 What is Diabetes?, 2010.