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Home » Exercise Programs » US FDA grants Fast Track designation to Jardiance (empagliflozin) to improve outcomes following a heart attack – BioSpace

RIDGEFIELD,Conn.andINDIANAPOLIS, Sept. 15, 2020 /PRNewswire/ --The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of Jardiance (empagliflozin) to prevent hospitalization for heart failure and reduce the risk of mortality in patients, with and without diabetes, who have had an acute myocardial infarction (more commonly known as a heart attack), Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced. More than 1.5 million heart attacks, which are the leading cause of heart failure and are associated with a high risk of death,occur annually in the U.S. A heart attack occurs as a result of reduced blood flow to part of the heart muscle.

"Ischemic heart disease (IHD) is the leading cause of death and disability in the U.S. Myocardial infarction, or heart attack, is the deadliest acute manifestation of IHD, and treatment options are urgently needed to help improve outcomes," said Mohamed Eid, M.D., M.P.H., M.H.A., vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. "We look forward to working closely with the FDA as we explore the potential for Jardiance to improve survival and prevent hospitalization for heart failure for adults who have had a heart attack, through our EMPACT-MI trial."

EMPACT-MI (A Streamlined, Multicenter, Randomized, Parallel Group, Double-blind Placebo-controlled Superiority Trial to Evaluate the Effect of EMPAgliflozin on Hospitalization for Heart Failure and Mortality in Patients With aCuTe Myocardial Infarction) is investigating the effect of Jardiance on all-cause mortality and hospitalization for heart failure in adults with and without type 2 diabetes who have had an acute myocardial infarction and no history of chronic heart failure. This randomized clinical phase III trial is being conducted, analyzed and reported in partnership with the Duke Clinical Research Institute (DCRI), with Boehringer Ingelheim and Lilly providing funding. EMPACT-MI is part of the EMPOWER clinical program, the broadest and most comprehensive clinical program for an SGLT2 inhibitor. EMPOWER explores the impact of Jardiance on the lives of people across the spectrum of cardio-renal-metabolic conditions.

Jardiance is a once-daily tablet used along with diet and exercise to lower blood sugar in adults with type 2 diabetes and to reduce the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease. Jardiance is contraindicated in patients with a history of serious hypersensitivity reaction to empagliflozin or any of the excipients of Jardiance, and in patients with severe renal impairment, end-stage renal disease, or dialysis. Jardiance is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

"The FDA Fast Track designation for Jardiance is an important milestone towards addressing an unmet need for people who have had a heart attack," said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly. "We remain committed to finding breakthrough outcomes for people with and without type 2 diabetes, including the prevention and treatment of heart failure. We look forward to learning the results of EMPACT-MI, which are anticipated in 2023."

About the EMPOWER programThe Alliance has developed the EMPOWER program to explore the impact of Jardiance on major clinical cardiovascular and renal outcomes in a spectrum of cardio-renal-metabolic conditions. Cardio-renal-metabolic conditions are the leading cause of mortality worldwide and account for up to 20 million deaths annually. Through the EMPOWER program, Boehringer Ingelheim and Lilly are working to advance knowledge of these interconnected systems and create care which offers integrated, multi-organ benefits. Comprised of eight clinical trials and two real-world evidence studies, EMPOWER reinforces the long-term commitment of the Alliance to improve outcomes for people living with cardio-renal-metabolic conditions. With more than 257,000 adults studied worldwide in clinical studies, it is the broadest and most comprehensive clinical program for an SGLT2 inhibitor to date.

The development program encompasses:

About Cardio-Renal-Metabolic ConditionsBoehringer Ingelheim and Lilly are driven to transform care for people with cardio-renal-metabolic conditions, a group of interconnected disorders that affect more than one billion people worldwide and are a leading cause of death.

The cardiovascular, renal and metabolic systems are interconnected, and share many of the same risk factors and pathological pathways along the disease continuum. Dysfunction in one system may accelerate the onset of others, resulting in progression of interconnected diseases such as type 2 diabetes, cardiovascular disease, heart failure, and kidney disease, which in turn leads to an increased risk of cardiovascular death. Conversely, improving the health of one system can lead to positive effects throughout the others.

Through our research and treatments, our goal is to support people's health, restoring the harmony between the interconnected cardio-renal-metabolic systems and reducing their risk of serious complications. As part of our commitment to those whose health is jeopardized by cardio-renal-metabolic conditions, we will continue embracing a multidisciplinary approach towards care and focusing our resources on filling treatment gaps.

WhatisJARDIANCE?(www.jardiance.com)

JARDIANCE isa prescriptionmedicine used alongwith dietandexercise to lowerblood sugarinadults withtype 2 diabetes.

JARDIANCE is also used to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.

JARDIANCEisnotforpeoplewith type 1 diabetesorforpeople with diabetic ketoacidosis(increased ketonesinthe blood or urine).

IMPORTANTSAFETYINFORMATIONDonottake JARDIANCEif you are allergicto empagliflozinoranyof the ingredientsin JARDIANCE.

Donottake JARDIANCEif you have severe kidneyproblemsorare ondialysis.

JARDIANCEcancauseserioussideeffects,including:

ThemostcommonsideeffectsofJARDIANCEincludeurinarytractinfectionsandyeastinfectionsin females.

ThesearenotallthepossiblesideeffectsofJARDIANCE.Formoreinformation,askyourdoctororpharmacist.

Before taking JARDIANCE, tellyourdoctorifyou:

Tellyourdoctoraboutallthe medicinesyou take, includingprescriptionand over-the-counter medicines, vitamins, andherbal supplements.Especiallytell yourdoctorifyou take waterpills (diuretics)ormedicinesthatcanloweryourbloodsugar,such asinsulin.

You are encouragedtoreportnegative side effectsofprescriptiondrugs totheFDA.Visit http://www.fda.gov/medwatchorcall1-800-FDA-1088.

Formoreinformation,pleaseseePrescribingInformationand Medication Guide.

CL-JAR-100057 01.27.2020

Boehringer Ingelheim and Eli Lilly and CompanyIn January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance that centers on compounds representing several of the largest diabetes treatment classes. Depending on geographies, the companies either co-promote or separately promote the respective molecules each contributing to the alliance. The alliance leverages the strengths of two of the world's leading pharmaceutical companies to focus on patient needs. By joining forces, the companies demonstrate their commitment, not only to the care of people with diabetes, but also to investigating the potential to address areas of unmet medical need. Clinical trials have been initiated to evaluate the impact of Jardiance on people living with heart failure or chronic kidney disease.

About Boehringer IngelheimMaking new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.

As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of around $21.3 billion (19 billion euros). Our significant investment of over $3.9 billion (3.5 billion euros) in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life.

We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation and is part of the Boehringer Ingelheim group of companies.In addition, there are Boehringer Ingelheim Animal Health in Duluth, GA and Boehringer Ingelheim Fremont, Inc. in Fremont, CA.

Boehringer Ingelheim is committed to improving lives and strengthening our communities. Please visit http://www.boehringer-ingelheim.us/csr to learn more about Corporate Social Responsibility initiatives.

For more information, please visit http://www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.

About Lilly DiabetesLilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research, collaboration and quality manufacturing we strive to make life better for people affected by diabetes and related conditions. We work to deliver breakthrough outcomes through innovative solutionsfrom medicines and technologies to support programs and more. For the latest updates, visit http://www.lillydiabetes.com/ or follow us on Twitter: @LillyDiabetes and Facebook: LillyDiabetesUS.

About Eli Lilly and CompanyLilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom.

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Jardiance and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that Jardiance will receive additional regulatory approvals. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

Jardiance and EMPA-REG OUTCOME areregistered trademarks of Boehringer Ingelheim.

P-LLYMPR-US-101382

CONTACT:Jennifer ForsythDirector, Public RelationsBoehringer Ingelheim Pharmaceuticals, Inc.Email: jennifer.forsyth@boehringer-ingelheim.comPhone: (203) 791-5889

Stephan Thalen Global Business CommunicationsLilly Diabetes and Lilly USAEmail: stephan.thalen@lilly.comPhone: (317) 903-5640

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SOURCE Eli Lilly and Company

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US FDA grants Fast Track designation to Jardiance (empagliflozin) to improve outcomes following a heart attack - BioSpace

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Home » Exercise Programs » US FDA grants Fast Track designation to Jardiance (empagliflozin) to improve outcomes following a heart attack – BioSpace