Lorcaserin Phase IIIb/IV Outcomes Study Assesses Incidence of Major Adverse Cardiovascular Events (MACE) in Patients with Overweight or Obesity
WOODCLIFF LAKE, NJ, USA I June 21, 2017 I Eisai Inc. today announced that the ongoing investigational CAMELLIA-TIMI 61 study of lorcaserin (marketed as BELVIQ® CIV) will continue as planned, based on the recommendation of an independent Data Monitoring Committee (DMC) after it completed a pre-specified interim safety analysis evaluating the incidence of MACE events, defined as cardiovascular death, myocardial infarction or stroke. The DMC will continue to monitor the ongoing safety of lorcaserin as planned.
The five-year study, comprised of 12,000 patients, is being conducted in partnership with the Thrombolysis in Myocardial Infarction (TIMI) Study Group and is intended to address the post-marketing requirement from the U.S. Food and Drug Administration to evaluate the long-term cardiovascular safety of lorcaserin.
The study is expected to conclude in 2018.
BELVIQ is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes). The safety and efficacy of coadministration of BELVIQ with other products intended for weight loss including prescription drugs (e.g., phentermine), over-the-counter drugs, and herbal preparations have not been established, nor has the effect of BELVIQ on cardiovascular morbidity and mortality.
About the Study
The CAMELLIA (Cardiovascular And Metabolic Effects of Lorcaserin In Overweight And Obese Patients) TIMI 61 study is the largest ongoing double-blind, placebo-controlled, parallel-group Phase IIIB/IV study among weight loss medications. The primary safety objective is to evaluate the incidence of major adverse cardiovascular events (MACE), defined as cardiovascular death, myocardial infarction or stroke. If the primary safety objective is met, the efficacy objective is to evaluate the impact of lorcaserin on the incidence of MACE+, defined as MACE or hospitalization due to unstable angina or heart failure, or any coronary revascularization. In addition, other secondary objectives include the evaluation of lorcaserin on glycemic control in patients with type 2 diabetes mellitus and the potential to delay or prevent the conversion from pre-diabetes to type 2 diabetes.
The effect of BELVIQ on cardiovascular morbidity has not been established. BELVIQ is not approved for use in the delay or prevention of diabetes.
About Obesity
Obesity is a serious and growing public health issue. The prevalence of obesity in the U.S. has more than doubled among adults in the past 30 years. Approximately 69 percent of American adults over the age of 20 are affected by obesity and overweight. This dramatic rise in obesity has also had a major impact on other diseases.
About Eisai Inc.
At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer’s disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US.
Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey and Pennsylvania, as well as a global demand chain organization that includes facilities in Maryland and North Carolina. Eisai’s global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs. Eisai’s global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.
About the TIMI Study Group
The TIMI Study Group is an Academic Research Organization based at Brigham and Women’s Hospital that has been leading practice-changing cardiovascular clinical trials for 30 years. Brigham and Women’s Hospital (BWH) is a 793-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare. BWH has more than 3.5 million annual patient visits, is the largest birthing center in New England and employs nearly 15,000 people.
SOURCE: Eisai
Post Views: 87
Lorcaserin Phase IIIb/IV Outcomes Study Assesses Incidence of Major Adverse Cardiovascular Events (MACE) in Patients with Overweight or Obesity
WOODCLIFF LAKE, NJ, USA I June 21, 2017 I Eisai Inc. today announced that the ongoing investigational CAMELLIA-TIMI 61 study of lorcaserin (marketed as BELVIQ® CIV) will continue as planned, based on the recommendation of an independent Data Monitoring Committee (DMC) after it completed a pre-specified interim safety analysis evaluating the incidence of MACE events, defined as cardiovascular death, myocardial infarction or stroke. The DMC will continue to monitor the ongoing safety of lorcaserin as planned.
The five-year study, comprised of 12,000 patients, is being conducted in partnership with the Thrombolysis in Myocardial Infarction (TIMI) Study Group and is intended to address the post-marketing requirement from the U.S. Food and Drug Administration to evaluate the long-term cardiovascular safety of lorcaserin.
The study is expected to conclude in 2018.
BELVIQ is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes). The safety and efficacy of coadministration of BELVIQ with other products intended for weight loss including prescription drugs (e.g., phentermine), over-the-counter drugs, and herbal preparations have not been established, nor has the effect of BELVIQ on cardiovascular morbidity and mortality.
About the Study
The CAMELLIA (Cardiovascular And Metabolic Effects of Lorcaserin In Overweight And Obese Patients) TIMI 61 study is the largest ongoing double-blind, placebo-controlled, parallel-group Phase IIIB/IV study among weight loss medications. The primary safety objective is to evaluate the incidence of major adverse cardiovascular events (MACE), defined as cardiovascular death, myocardial infarction or stroke. If the primary safety objective is met, the efficacy objective is to evaluate the impact of lorcaserin on the incidence of MACE+, defined as MACE or hospitalization due to unstable angina or heart failure, or any coronary revascularization. In addition, other secondary objectives include the evaluation of lorcaserin on glycemic control in patients with type 2 diabetes mellitus and the potential to delay or prevent the conversion from pre-diabetes to type 2 diabetes.
The effect of BELVIQ on cardiovascular morbidity has not been established. BELVIQ is not approved for use in the delay or prevention of diabetes.
About Obesity
Obesity is a serious and growing public health issue. The prevalence of obesity in the U.S. has more than doubled among adults in the past 30 years. Approximately 69 percent of American adults over the age of 20 are affected by obesity and overweight. This dramatic rise in obesity has also had a major impact on other diseases.
About Eisai Inc.
At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer’s disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US.
Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey and Pennsylvania, as well as a global demand chain organization that includes facilities in Maryland and North Carolina. Eisai’s global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs. Eisai’s global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.
About the TIMI Study Group
The TIMI Study Group is an Academic Research Organization based at Brigham and Women’s Hospital that has been leading practice-changing cardiovascular clinical trials for 30 years. Brigham and Women’s Hospital (BWH) is a 793-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare. BWH has more than 3.5 million annual patient visits, is the largest birthing center in New England and employs nearly 15,000 people.
SOURCE: Eisai
Post Views: 87
