Top Page | English | 简体中文 | 繁體中文 | 한국어 | 日本語
Tuesday, 28 August 2018, 09:11 HKT/SGT
Share:
    

Source: Eisai
Eisai: Long-Term Cardiovascular Outcomes Data for Anti-Obesity Agent BELVIQ
Presented at The European Society of Cardiology and Published in the New England Journal of Medicine

TOKYO, Aug 28, 2018 - (JCN Newswire) - The average change in weight from baseline was -4.2 kg with BELVIQ and -1.4 kg with placebo, translating to a 2.8 kg greater net weight loss with BELVIQ (nominal p-value<0.001).

Furthermore, treatment with BELVIQ (for a period of one year), on top of standard of care for the respective comorbid conditions in CAMELLIA-TIMI 61, was associated with statistically significant improvements in systolic blood pressure (placebo-subtracted difference -0.9 mm Hg), diastolic blood pressure (-0.8 mm Hg), heart rate (-1.0 beat per minute), low-density lipoprotein cholesterol (-1.2 mg/dL), triglycerides (-11.7 mg/dL) and non-high-density lipoprotein cholesterol (-2.6 mg/dL).

BELVIQ also reduced hemoglobin A1C (HBA1c) in patients with T2DM at baseline (placebo-subtracted difference -0.3%) and reduced the rate of new onset diabetes in patients with pre-diabetes at baseline (3.1%/year with BELVIQ versus 3.8%/year with placebo).

No significant differences were seen in the overall incidence of serious adverse events between BELVIQ and placebo (31% vs. 32%), and the overall safety profile for BELVIQ in CAMELLIA-TIMI 61 was consistent with that of the approved label. Dizziness, fatigue, headache, nausea and diarrhea were the most commonly reported adverse events in CAMELLIA-TIMI 61. Adverse events possibly leading to study discontinuation were more frequent with BELVIQ versus placebo (7.2% vs. 3.7%), with the most commonly reported adverse events in this category for BELVIQ being dizziness, fatigue, headache, diarrhea and nausea.

Further results of analyses of the study will be presented on October 4 at the European Association for Study of Diabetes (EASD) Annual Meeting held in Berlin, Germany.

By continuing to provide additional clinical and scientific information regarding BELVIQ, Eisai continues to make further contributions to address unmet medical needs 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 the Cardiovascular Outcomes Trial, CAMELLIA-TIMI61 Study

The CAMELLIA (Cardiovascular And Metabolic Effects of Lorcaserin In Overweight And Obese Patients) TIMI 61 study was the largest double-blind, placebo-controlled, parallel-group Phase IIIB/IV study among weight loss medications. The primary safety objective was to evaluate the incidence of major adverse cardiovascular events (MACE), defined as cardiovascular death, myocardial infarction or stroke. If the primary safety objective was met, the efficacy objective was 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. Secondary objectives included evaluation for the potential to delay or prevent conversion to T2DM in patients with pre-diabetes or no diabetes at baseline and improvement of glycemic control in patients with T2DM.

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.

About The New England Journal of Medicine

The New England Journal of Medicine (NEJM) is the world's leading medical journal and website, published continuously for over 200 years. NEJM has the highest Journal Impact Factor of all general medical journals (2017 Journal Citation Reports, Clarivate Analytics, 2018).


About Eisai

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to address unmet medical needs, with a particular focus in our strategic areas of Oncology and Neurology.

As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit www.eisai.com.

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


Aug 28, 2018 09:11 HKT/SGT
Source: Eisai

Eisai (TSE: 4523)

Topic: Press release summary
Sectors: BioTech
http://www.acnnewswire.com
From the Asia Corporate News Network


Copyright © 2018 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.



Eisai
Dec 17, 2018 08:21 HKT/SGT
Eisai Signs Collaboration Agreement for Anti-Obesity Agent Lorcaserin in Brazil with Eurofarma
Dec 12, 2018 09:06 HKT/SGT
GARDP, Eisai and Takeda Announce Partnership in the Search for New Antibiotics
Dec 6, 2018 09:24 HKT/SGT
Eisai and UCL Commence Preparations for Phase I Clinical Studies in Alzheimer's Disease for Novel Anti-Tau Antibody E2814 Discovered Through Joint Research
Nov 29, 2018 13:48 HKT/SGT
Eisai: MOVICOL Launched in Japan
Nov 28, 2018 10:55 HKT/SGT
Eisai: Primary Endpoint Met in Phase III Clinical Study of Fycompa
Nov 27, 2018 17:02 HKT/SGT
Eisai to Present New Research on Eribulin (Halaven) at 41st Annual San Antonio Breast Cancer Symposium
Nov 23, 2018 07:14 HKT/SGT
Eisai to Present Latest Data on Perampanel at 72nd American Epilepsy Society Annual Meeting
Nov 14, 2018 12:30 HKT/SGT
Eisai Receives "IR Grand Prix Award"
Nov 12, 2018 11:51 HKT/SGT
Eisai Launches Lenvima (Lenvatinib) in China
Nov 9, 2018 08:08 HKT/SGT
Eisai: New Data from Investigational Study of Lenvima (Lenvatinib) and Keytruda (Pembrolizumab) Combination in Three Different Tumor Types Presented at the Society for Immunotherapy of Cancer's 33rd Annual Meeting
More news >>
 News Alerts
Copyright © 2018 ACN Newswire - Asia Corporate News Network
Home | About us | Services | Partners | Events | Login | Contact us | Privacy Policy | Terms of Use | RSS
US: +1 800 291 0906 | Beijing: +86 10 8405 3688 | Hong Kong: +852 2217 2912 | Singapore: +65 6304 8926 | Tokyo: +81 3 6721 7212

Connect With us: