Eisai announced positive topline results from the CAMELLIA-TIMI 61 cardiovascular outcome trial. This 12,000 patient study of BELVIQ (lorcaserin HCl) CIV 10 mg twice-daily was conducted at over 400 sites in eight countries including the United States in collaboration with the Thrombolysis in Myocardial Infarction (TIMI) Study Group and is the largest cardiovascular (CV) outcome trial to date for a weight loss medication. The study was conducted as part of a post-marketing requirement by the U.S. Food and Drug Administration (FDA) with the primary objective to evaluate long-term cardiovascular safety and assessed for the incidence of major adverse cardiovascular events (MACE) in overweight and obese adults with existing cardiovascular disease or type 2 diabetes mellitus (T2DM) with cardiovascular risk factors.
CAMELLIA-TIMI 61 met its primary safety objective, finding that long-term treatment with BELVIQ does not increase incidence of MACE, defined as cardiovascular death or non-fatal myocardial infarction or non-fatal stroke, in overweight and obese patients at high risk for CV events. With this result, BELVIQ is the first- ever weight loss medication approved for chronic weight management to achieve this objective in a dedicated long-term cardiovascular outcome trial.
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Since the study met the primary safety endpoint for MACE, the study also assessed for the primary efficacy endpoint of whether or not BELVIQ reduced the incidence of cardiovascular events compared to placebo for a broader composite endpoint, MACE+, consisting of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalization due to unstable angina, heart failure or coronary revascularization. Although superiority to placebo was not met, BELVIQ was non-inferior to placebo on the MACE+ composite, with similar event rates for BELVIQ and placebo.
CAMELLIA-TIMI 61 also assessed for effects of BELVIQ on multiple cardiovascular risk factors. On top of standard of care for CV risk management, treatment with BELVIQ resulted in significant improvements in a number of predefined secondary endpoints, including blood pressure, lipids, blood sugar and renal function, as well as a reduction in conversion to T2DM in patients without diabetes at baseline.
In additional subgroup analyses, on a background of lifestyle modification, it was observed that BELVIQ improved long-term weight loss, compared to placebo, including in subpopulations of patients with T2DM and obstructive sleep apnea.
The overall safety profile for BELVIQ in CAMELLIA-TIMI 61 was consistent with that of the approved label, with dizziness, urinary tract infection, and fatigue being the most commonly reported adverse events in CAMELLIA-TIMI61.
"Obesity is a major problem globally and associated with increased risk for heart disease and other serious health conditions such as hypertension, type 2 diabetes and obstructive sleep apnea," said Lynn Kramer, M.D., Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. "The results for BELVIQ from this robust global study provide important information to health care providers and patients, particularly those with cardiovascular and obesity-related complications."
Eisai and the TIMI Study Group will present results of the CAMELLIA-TIMI 61 study at the European Society for Cardiology (ESC) Meeting in Munich, Germany on August 26 and the European Association for Study of Diabetes (EASD) Meeting in Berlin, Germany on October 4.
With the results of this study, Eisai will have discussions with the U.S. FDA, including potential revision of the product label to include meaningful and important information for prescribers. 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.