INDIANAPOLIS, IN, USA I September 20, 2019 I Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending an update to the Trulicity® (dulaglutide) label and indication statement. The committee agreed the label should include results from the REWIND cardiovascular (CV) outcomes trial, which achieved a significant 12 percent risk reduction in major adverse cardiovascular events (MACE).
The CHMP has recommended updating the Trulicity® indication to reflect both glycemic control and the impact on cardiovascular events as fundamental considerations in a treatment for people with type 2 diabetes. Additionally, the updated label will reflect the consistent MACE risk reduction with Trulicity across major demographic and disease subgroups.
“Millions of people with diabetes are at a higher risk for developing cardiovascular disease. The REWIND trial found that Trulicity significantly reduced major cardiovascular events and had a consistent effect in people with and without established cardiovascular disease,” said Dawn Brooks, Ph.D., global development leader, Trulicity, Lilly. “We are pleased with this opinion recognizing the importance of these data, which demonstrate the benefits of Trulicity in a broad range of people with type 2 diabetes.”
REWIND is the longest CV outcomes trial in the glucagon-like peptide-1 receptor agonist (GLP-1 RA) class (median follow-up of 5.4 years) and consisted primarily of people without established CV disease. The study had a more balanced ratio of women (46.3 percent) to men (53.7 percent) and one of the lowest median baseline A1Cs of any diabetes CV outcome trial to date (7.2 percent).
This decision is now referred for final action to the European Commission, which grants approval in the European Union.
About the REWIND Study
REWIND (Researching cardiovascular Events with a Weekly INcretin in Diabetes) was a multicenter, randomized, double-blind, placebo-controlled trial designed to assess the effect of Trulicity 1.5 mg, a weekly GLP-1 RA, compared to placebo, both added to standard of care (according to local standard of care guidelines), on CV events in adults with type 2 diabetes. The primary endpoint was the first occurrence of MACE (the composite of CV death or non-fatal myocardial infarction or non-fatal stroke). Secondary endpoints included each component of the primary composite endpoint, a composite clinical microvascular endpoint comprising retinal or renal disease, hospitalization for unstable angina, heart failure requiring hospitalization or an urgent heart failure visit, and all-cause mortality. The 9,901 participants from 24 countries had a mean duration of diabetes of 10.5 years and a median baseline HbA1c of 7.2 percent. While all participants had CV risk factors, only 31 percent of the study participants had established CV disease. Prior (or established) CV disease in REWIND was defined as prior myocardial infarction, prior ischemic stroke, prior unstable angina, prior revascularization (coronary, carotid, or peripheral), prior hospitalization for ischemia-related events (unstable angina or myocardial ischemia on imaging, or need for percutaneous coronary intervention), or prior documented myocardial ischemia.
The REWIND trial’s international scope, high proportion of women, high proportion of people without established CV disease and inclusion of participants with a lower mean baseline HbA1c suggest that the findings will be directly relevant to the typical patient with type 2 diabetes seen in general practice throughout the world.
Indication and Limitations of Use for Trulicity
Trulicity is a once-weekly injectable prescription medicine to improve blood sugar (glucose) in adults with type 2 diabetes (mellitus). It should be used along with diet and exercise.
Trulicity is not recommended as the first medication to treat diabetes. It has not been studied in people who have had inflammation of the pancreas (pancreatitis). Trulicity should not be used by people with type 1 diabetes, people with diabetic ketoacidosis, or people with a history of severe gastrointestinal (GI) disease. It is not a substitute for insulin. It has not been studied in children under 18 years of age.
About Diabetes
Approximately 425 million adults worldwide have diabetes.1 Type 2 diabetes is the most common type internationally, accounting for an estimated 90 to 95 percent of all diabetes cases.2 Diabetes is a chronic disease that occurs when the body does not properly produce or use the hormone insulin.1
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 are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research and collaboration, a broad and growing product portfolio and a continued determination to provide real solutions—from medicines to support programs and more—we strive to make life better for all those affected by diabetes around the world. For more information, visit www.lillydiabetes.com or follow us on Twitter: @LillyDiabetes.
About Eli Lilly and Company
Lilly is a global healthcare 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 www.lilly.com and http://newsroom.lilly.com/social-channels. P-LLY
| 1. |
International Diabetes Federation. IDF Diabetes Atlas, 8th edn. Brussels, Belgium: International Diabetes Federation, 2017. http://www.diabetesatlas.org. |
| 2. |
Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2017. Atlanta, GA: Centers for Disease Control and Prevention, U.S. Dept of Health and Human Services; 2017. |
SOURCE: Eli Lilly
Post Views: 19
INDIANAPOLIS, IN, USA I September 20, 2019 I Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending an update to the Trulicity® (dulaglutide) label and indication statement. The committee agreed the label should include results from the REWIND cardiovascular (CV) outcomes trial, which achieved a significant 12 percent risk reduction in major adverse cardiovascular events (MACE).
The CHMP has recommended updating the Trulicity® indication to reflect both glycemic control and the impact on cardiovascular events as fundamental considerations in a treatment for people with type 2 diabetes. Additionally, the updated label will reflect the consistent MACE risk reduction with Trulicity across major demographic and disease subgroups.
“Millions of people with diabetes are at a higher risk for developing cardiovascular disease. The REWIND trial found that Trulicity significantly reduced major cardiovascular events and had a consistent effect in people with and without established cardiovascular disease,” said Dawn Brooks, Ph.D., global development leader, Trulicity, Lilly. “We are pleased with this opinion recognizing the importance of these data, which demonstrate the benefits of Trulicity in a broad range of people with type 2 diabetes.”
REWIND is the longest CV outcomes trial in the glucagon-like peptide-1 receptor agonist (GLP-1 RA) class (median follow-up of 5.4 years) and consisted primarily of people without established CV disease. The study had a more balanced ratio of women (46.3 percent) to men (53.7 percent) and one of the lowest median baseline A1Cs of any diabetes CV outcome trial to date (7.2 percent).
This decision is now referred for final action to the European Commission, which grants approval in the European Union.
About the REWIND Study
REWIND (Researching cardiovascular Events with a Weekly INcretin in Diabetes) was a multicenter, randomized, double-blind, placebo-controlled trial designed to assess the effect of Trulicity 1.5 mg, a weekly GLP-1 RA, compared to placebo, both added to standard of care (according to local standard of care guidelines), on CV events in adults with type 2 diabetes. The primary endpoint was the first occurrence of MACE (the composite of CV death or non-fatal myocardial infarction or non-fatal stroke). Secondary endpoints included each component of the primary composite endpoint, a composite clinical microvascular endpoint comprising retinal or renal disease, hospitalization for unstable angina, heart failure requiring hospitalization or an urgent heart failure visit, and all-cause mortality. The 9,901 participants from 24 countries had a mean duration of diabetes of 10.5 years and a median baseline HbA1c of 7.2 percent. While all participants had CV risk factors, only 31 percent of the study participants had established CV disease. Prior (or established) CV disease in REWIND was defined as prior myocardial infarction, prior ischemic stroke, prior unstable angina, prior revascularization (coronary, carotid, or peripheral), prior hospitalization for ischemia-related events (unstable angina or myocardial ischemia on imaging, or need for percutaneous coronary intervention), or prior documented myocardial ischemia.
The REWIND trial’s international scope, high proportion of women, high proportion of people without established CV disease and inclusion of participants with a lower mean baseline HbA1c suggest that the findings will be directly relevant to the typical patient with type 2 diabetes seen in general practice throughout the world.
Indication and Limitations of Use for Trulicity
Trulicity is a once-weekly injectable prescription medicine to improve blood sugar (glucose) in adults with type 2 diabetes (mellitus). It should be used along with diet and exercise.
Trulicity is not recommended as the first medication to treat diabetes. It has not been studied in people who have had inflammation of the pancreas (pancreatitis). Trulicity should not be used by people with type 1 diabetes, people with diabetic ketoacidosis, or people with a history of severe gastrointestinal (GI) disease. It is not a substitute for insulin. It has not been studied in children under 18 years of age.
About Diabetes
Approximately 425 million adults worldwide have diabetes.1 Type 2 diabetes is the most common type internationally, accounting for an estimated 90 to 95 percent of all diabetes cases.2 Diabetes is a chronic disease that occurs when the body does not properly produce or use the hormone insulin.1
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 are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research and collaboration, a broad and growing product portfolio and a continued determination to provide real solutions—from medicines to support programs and more—we strive to make life better for all those affected by diabetes around the world. For more information, visit www.lillydiabetes.com or follow us on Twitter: @LillyDiabetes.
About Eli Lilly and Company
Lilly is a global healthcare 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 www.lilly.com and http://newsroom.lilly.com/social-channels. P-LLY
| 1. |
International Diabetes Federation. IDF Diabetes Atlas, 8th edn. Brussels, Belgium: International Diabetes Federation, 2017. http://www.diabetesatlas.org. |
| 2. |
Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2017. Atlanta, GA: Centers for Disease Control and Prevention, U.S. Dept of Health and Human Services; 2017. |
SOURCE: Eli Lilly
Post Views: 19
