Jun 23, 2017 11:39 JST

Source: Eisai

Cardiovascular Outcomes Trial of Anti-Obesity Agent Lorcaserin to Continue Based on Recommendation of Independent Data Monitoring Committee After Completion of Interim Safety Analysis

TOKYO, Jun 23, 2017 - (JCN Newswire) - Eisai Co., Ltd. has announced that it has received a recommendation from an independent Data Monitoring Committee to continue the ongoing Cardiovascular Outcomes Trial (CAMELLIA-TIMI61 Study) of lorcaserin hydrochloride (U.S. brand name: BELVIQ, "lorcaserin") after the completion of a pre-specified interim safety analysis, evaluating the incidence of Major Adverse Cardiovascular Events (MACE), defined as cardiovascular death, myocardial infarction or stroke. Based on this recommendation, Eisai will continue the study as planned. Topline results for this study are expected in FY 2018.

This Phase IIIb/IV clinical study, comprised of 12,000 patients, is being conducted over a 5-year period 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.

Lorcaserin has been marketed under the brand name BELVIQ in the United States since June 2013 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).

Through BELVIQ, Eisai continues to make further contributions to address unmet medical needs in the clinical management of obesity and increase the benefits for patients and their families.

About lorcaserin hydrochloride (U.S. brand name: BELVIQ, once daily formulation U.S. brand name: BELVIQ XR)

Discovered and developed by Arena Pharmaceuticals, Inc. (Headquarters: California, United States, President and CEO: Amit D. Munshi), lorcaserin is a novel chemical entity that is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain. Activation of these receptors may help a person eat less and feel full after eating smaller amounts of food. Lorcaserin was approved in June 2012 by the FDA as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients 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, and was launched in the United States under the brand name BELVIQ in June 2013 after receiving a final scheduling designation from the U.S. Drug Enforcement Administration (DEA). In addition, lorcaserin has been made available in South Korea via a third-party distributor from 2015. Lorcaserin was approved in Mexico in July 2016 and in Brazil in December 2016, with the same indication as for the United States.

Furthermore, BELVIQ XR, a once-daily formulation of lorcaserin aiming to increase convenience of administration for patients, was approved in the United States in July 2016.

In January 2017, Eisai acquired all of Arena's rights to develop and market BELVIQ.

The most common adverse reactions observed in multiple Phase III clinical studies on lorcaserin were headache, dizziness, fatigue, nausea, dry mouth and constipation in patients without diabetes, and hypoglycemia, headache, back pain, cough and fatigue in patients with diabetes. For further information on lorcaserin in the United States, including Important Safety Information (ISI), please visit the BELVIQ product website (http://www.belviq.com).

About Cardiovascular Outcomes Trials, CAMELLIA-TIMI61 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.

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.

Contact:
Public Relations Department
Eisai Co., Ltd.
+81-(0)3-3817-5120
Source: Eisai
Sectors: BioTech

Copyright ©2024 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.

Related Press Release


Eisai to Divest Rights for Merislon and Myonal in Japan to Kaken Pharmaceutical
March 29 2024 14:51 JST
 
Eisai's Brain Health Self-Check Tool "NouKNOW" is Certified as "ME-BYO BRAND" by Kanagawa Prefecture
March 29 2024 14:19 JST
 
Eisai: Discovery Research on Dual Orexin Receptor Antagonist Lemborexant Honored with PSJ Award for Drug Research and Development 2024
March 29 2024 13:32 JST
 
Lifenet and Eisai Co-Develop Dementia Insurance "be"
March 21 2024 16:36 JST
 
Eisai Selected as a Nadeshiko Brand 2024 as a Listed Company Excelling in Promotion of Women in the Workplace
March 21 2024 15:10 JST
 
Eisai Invests in C2N to Support Simplifying the Diagnosis of Early Alzheimer's Disease to Better Serve Patients
March 06 2024 16:47 JST
 
Eisai to Boost Initiatives on Greenhouse Gas Reduction, Aiming to Achieve Net Zero by 2050
February 21 2024 14:26 JST
 
Eisai Selected for 'Human Capital Leaders 2023' and 'Human Capital Management Gold Quality', Recognized as Company Committed to Excellent Management and Disclosure of Human Capital Initiatives
February 20 2024 08:35 JST
 
Eisai: Metoject Subcutaneous Injection Pen (Methotrexate) Pen-Type Autoinjector Approved in Japan
February 16 2024 08:31 JST
 
Eisai Commences Fully-Fledged Business Activities at Pharma Sales Subsidiary in South Africa
February 01 2024 17:04 JST
 
More Press release >>

Latest Press Release


More Latest Release >>