Japan : Cardiovascular Outcomes Trial of Anti-obesity Agent Lorcaserin to Continue Based on Recommendation of Independent Data Monitoring Committee After Completion of Interim Safety Analysis.
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 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/m or greater (obese), or 27 kg/m 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.
[c] 2017 Al Bawaba (Albawaba.com) Provided by SyndiGate Media Inc. ( Syndigate.info ).
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|Date:||Jun 23, 2017|
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