Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) to potentially update the label for BELVIQ® (lorcaserin HCl) CIV 10 mg twice-daily/BELVIQ XR (lorcaserin HCl) CIV once daily to include long-term efficacy and safety data from CAMELLIA-TIMI 61, a clinical trial of BELVIQ in 12,000 overweight and obese patients with cardiovascular (CV) disease and/or multiple CV risk factors such as type 2 diabetes mellitus (T2DM).
The addition of this data has the potential for a revision to the product label’s Indications and Usage, removing the Limitation of Use related to the effect of BELVIQ on CV morbidity and mortality.
As previously reported and published in the New England Journal of Medicine on August 26th, CAMELLIA-TIMI 61 met its primary safety objective, finding that long-term treatment with BELVIQ did not increase the incidence of major adverse cardiovascular events (MACE) in overweight and obese patients at high risk for a CV event (HR 0.99; 95% CI: 0.85 to 1.14; p<0.001). Since the study met the primary safety endpoint for non-inferiority for MACE, the study continued to assess for the primary efficacy endpoint of whether or not BELVIQ reduced the incidence of major CV events compared to placebo for a broader composite endpoint, MACE+, consisting of CV 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.
“This sNDA file acceptance brings us one step closer to potentially incorporating data into our label based on the first completed large-scale cardiovascular outcomes trial for a weight loss agent,” said Lynn Kramer, M.D., Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. “We are excited about our data as it showed BELVIQ did not increase the incidence of MACE and look forward to continuing our discussions with the FDA.”