Решением Совета Евразийской экономической комиссии от 4 июля 2023 года №76 внесены изменения в правила надлежащей производственной практики Евразийского экономического союза. Об этом сообщает ККМФД МЗ РК.

- CHMP's positive finding is based on the landmark EMPA-KIDNEY study, the largest and most widely specialized study of SGLT2 inhibitors in chronic kidney disease (CKD) to date ^1,2,3 ;
- If approved, Jardins® (empagliflozin) could improve the standard of care for the more than 47 million people in the European Union living with CKD and other related cardio-renal and metabolic diseases ⁴ .

Ingelheim, Germany and Indianapolis, USA. July 19, 2023 - Boehringer Ingelheim and Eli Lilly and Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a favorable opinion recommending Jardiance® (empagliflozin) for treatment of adults with chronic kidney disease (CKD). ¹ Empagliflozin is currently indicated for the treatment of heart failure and type 2 diabetes in adults. ⁵ If approved, the EU indications for empagliflozin would be extended to adults with CKD, providing an approach to manage the increased risk of associated cardiovascular and metabolic diseases.

"The EMPA-KIDNEY study, upon which the CHMP recommendation is based, demonstrated clear benefits with respect to its primary outcomes based on progression of kidney disease and death from cardiovascular disease in a wide range of adults with chronic kidney disease," said Professor William Herrington, researcher is a clinician at the Division of Population Health Research, Oxford University Medical Research Council, UK, and EMPA-KIDNEY Principal Investigator. "Approval of empagliflozin should greatly help translate these important findings into clinical practice for people living with chronic kidney disease," added study co-lead Professor Richard Haynes.

The phase III EMPA-KIDNEY study enrolled 6609 adults with varying degrees of CKD severity with a wide range of underlying causes and comorbidities, making EMPA-KIDNEY the largest and most highly specialized study of SGLT2 inhibitors in CKD to date. Empagliflozin demonstrated significant renal and cardiovascular benefit in adults with CKD, reducing the relative risk of progression of kidney disease or death from cardiovascular disease by 28% compared with placebo. ^2.3

"More than 47 million people in the EU are living with chronic kidney disease and even more with cardio-renal and metabolic diseases," said Carinne Brouillon, Head of Human Pharma at Boehringer Ingelheim. "We are very excited that empagliflozin can play a key role in the treatment of these interrelated cardio-renal and metabolic diseases."

“Cardio-renal and metabolic diseases such as chronic kidney disease, type 2 diabetes and heart failure are the leading cause of death in Europe. We will continue to work closely with regulators around the world to ensure that adult patients living with chronic kidney disease and health care professionals can benefit from empagliflozin as quickly as possible,” continued Leonard Glass, MD, Fellow of the American Endocrinology Association, Senior Vice President. President of Diabetes & Obesity Global Medical Affairs, Lilly.

About EMPA-KIDNEY: Empagliflozin Heart and Kidney Protection Study ^2,3,6

EMPA-KIDNEY (NCT03594110) is an international, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effect of empagliflozin on the progression of kidney disease and the risk of cardiovascular mortality. The primary outcome is defined as the time to the first event of either death from cardiovascular disease or progression of kidney disease, defined as end-stage kidney disease (need for renal replacement therapy such as dialysis or kidney transplant), sustained decline in eGFR to <10 ml/day min/1.73 m2, kidney death, or sustained decrease in eGFR by ≥40 percent as a result of randomization. Key secondary outcomes include cardiovascular death or hospitalization for heart failure, hospitalization for any reason and overall mortality. EMPA-KIDNEY included 6,609 adults randomized from eight countries with established chronic kidney disease with or without diabetes, and with or without albuminuria, to receive either empagliflozin 10 mg or placebo in addition to current standard of care .

About Chronic Kidney Disease

Chronic kidney disease affects approximately 850 million people worldwide, representing more than 10 percent of the population. ⁷ This condition is caused by progressive damage to the kidneys that prevents them from working properly. Because the disease is mostly asymptomatic until later stages of the disease, most people go undiagnosed, and millions of people die prematurely every year from chronic kidney disease and its associated complications. ^6,8,9 The Boehringer Ingelheim and Lilly Alliance is committed to transforming the care of people with chronic kidney disease and other cardio-renal metabolic diseases.

About Cardio-Renal and Metabolic Diseases

Boehringer Ingelheim and Lilly are committed to transforming the care of people with heart and kidney and metabolic diseases, a group of interrelated diseases that affect more than 1.4 billion people worldwide and are a leading cause of death. ^10.11

The cardiovascular, renal, and metabolic systems are interrelated and share many of the same risk factors and pathological pathways throughout the disease cycle. Dysfunction in one system can accelerate the onset of others, leading to the progression of interrelated diseases such as type 2 diabetes, cardiovascular disease, heart failure, and kidney disease, which in turn leads to an increased risk of death from cardiovascular disease. Conversely, improvements in one system can lead to a positive effect in all others. ^12,13,14

Our research and treatments aim to keep people healthy by restoring balance between the interconnected cardio-renal and metabolic systems and reducing the risk of serious complications. As part of our commitment to those whose health is at risk due to cardio-renal and metabolic diseases, we will continue to take a multidisciplinary approach to treatment and focus our resources on filling gaps in existing care.

About empagliflozin

Empagliflozin (trade name Jardines®) is a highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor for oral administration once daily. It is the first drug for type 2 diabetes with evidence in several countries to reduce the risk of death from cardiovascular disease. ^15.16

Boehringer Ingelheim and Eli Lilly and Company

The Boehringer Ingelheim and Lilly alliance leverages the strengths of two of the world's leading pharmaceutical companies. By joining forces, the companies are demonstrating their commitment not only to treating people with type 2 diabetes, but also to addressing unmet medical needs in areas such as heart failure and chronic kidney disease.

About Boehringer Ingelheim

Boehringer Ingelheim is working on revolutionary treatments that are changing people's lives today and for generations to come. As a leading research-driven biopharmaceutical company, Boehringer Ingelheim delivers value through innovation in areas where there is high unmet medical need. The company, founded in 1885, is a family business with a long-term and sustainable vision. Over 53,000 employees serve over 130 markets across two business units, Human Pharma and Animal Health. Find out more at www.boehringer-ingelheim.com .

Sources:

¹ Committee on Medicinal Products for Human Use (CHMP). Summary of Jardiance's Conclusion. Available at: https://www.ema.europa.eu/en/documents/smop/chmp-post-authorization-summary-positive-opinion-jardiance-ii-74_en.pdf. Access: June 2023

² EMPA-KIDNEY Complete Data Presentation presented November 4, 2022 at the American Society of Nephrology (ASN) Congress 2022 - Kidney Week.

³ Herrington W, Steplin N, Vanner S et al. Empagliflozin in patients with chronic kidney disease. N Engl J Med . 2023; 388:117-127.

⁴ Bikbov B. et al. Global, regional and national burden of chronic kidney disease, 1990–2017: a systematic analysis for the study of the global burden of disease, 2017 Lancet . 2020;395(10225):709-733.

⁵ EMC. Jardins ^® (Jardiance ^® ) 10 mg film-coated tablets. Product Feature Summary (SmPC). Available at the link:https://www.medicines.org.uk/emc/product/5441/smpc#gref. Access: June 2023

⁶ Clinical studies. EMPA-KIDNEY (Empagliflozin Heart and Kidney Protection Study). Available at:https://clinicaltrials.gov/ct2/show/NCT03594110 . Access: June 2023

⁷ Li P et al. Braz J Med Biol Res . 2020; 53(3): e9614.

⁸ Koresh J. Update on the burden of CKD. J Am Soc Nephrol . 2017;28(4):1020–1022.

⁹ Lucks W. et al. Bull World Health Organ . 2018;96(6):414–422D.

¹⁰ Schechter, M. et al. Cardiovasc Diabetol . 2022:21;104.

¹¹ Sundstrom J. et al. CaReMe CKD. Lancet Reg Health Eur . June 30, 2022;20:100438.

¹² Thomas M, Cooper M, Zimmet P. Changing epidemiology of type 2 diabetes mellitus and associated chronic kidney disease. Nat Rev Nephrol . 2015;12:73–81.

¹³ Garcia-Doner A, Ruylop M. Cardiovascular and renal connections along the cardio-renal continuum. Int J Nephrol . 2011:975782.

¹⁴ Leon M, Maddox M. Diabetes and cardiovascular disease: epidemiology, biological mechanisms, treatment recommendations, and future research. World J Diabetes . 2015;6(13):1246–58.

¹⁵ Jardins ^® (Jardiance ^® ) (empagliflozin) tablets. European Product Information, approved April 2020. Available at:https://www.ema.europa.eu/en/documents/product-information/jardiance-epar-product-information_en.pdf . Access: June 2023

¹⁶ Jardiance ^{® (empagliflozin )} Tablets US Prescribing Information. Available at:http://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Jardiance/jardiance.pdf . Access: June 2023

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