FDA accepts request for CV safety data inclusion for obesity drug

The FDA on Monday accepted a supplemental new drug application requesting a label update for the serotonin receptor agonist lorcaserin to include new cardiovascular safety data, according to a press release from Eisai.

The request follows results from the CAMELLIA-TIMI 61 study presented at the European Society of Cardiology Congress in August, which demonstrated that treatment with lorcaserin (Belviq) yielded sustained weight loss during a median follow-up of 3 years without an excess risk for major adverse CV events in adults with overweight or obesity at high CV risk.

The addition of the study data could lead to a revision to the product label’s Indications and Usage, removing the Limitation of Use related to the effect of lorcaserin on CV morbidity and mortality, according to Eisai.

“This [supplemental] NDA 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,” Lynn Kramer, MD, chief clinical officer and chief medical officer of the neurology business group for Eisai, said in the release. “We are excited about our data, as it showed Belviq did not increase the incidence of [major adverse CV events], and look forward to continuing our discussions with the FDA.”

In CAMELLIA-TIMI 61, a randomized, double-blind, placebo-controlled trial of more than 12,000 patients with atherosclerotic CVD or multiple CV risk factors, the primary safety outcome of major adverse CV events — a composite of CV death, myocardial infarction or stroke — occurred in 6.1% of the lorcaserin group vs. 6.2% of the placebo group (HR = 0.99; 95% CI, 0.85-1.14; P for noninferiority < .001). The annualized rate of major adverse CV events was 2% for the lorcaserin group vs. 2.1% for the placebo group.

The primary efficacy outcome was a composite of CV death, MI, stroke, hospitalization for unstable angina, heart failure or any coronary revascularization, which occurred in 11.8% of the lorcaserin group vs. 12.1% of the placebo group (HR = 0.97; 95% CI, 0.87-1.07; P for superiority = .55). The annualized rate of extended major CV events was 4.1% for the lorcaserin group vs. 4.2% for the placebo group.

Researchers also found no increased risk for new or worsening valvulopathy in patients assigned lorcaserin compared with placebo, which has been a concern with other weight-loss drugs.

The application follows an FDA-approved label change in October for the 3 mg dose of liraglutide (Saxenda, Novo Nordisk) to include data showing that the medication does not increase the risk for major CV events. As Endocrine Today previously reported, the change was based on results from the LEADER trial, which demonstrated a 13% reduced risk for a three-component endpoint of CV death, nonfatal MI and nonfatal stroke with liraglutide 1.8 mg (Victoza, Novo Nordisk) compared with placebo (P = .01), according to the company. – by Regina Schaffer

Disclosure: Kramer reports he is chief clinical officer and chief medical officer of the neurology business group for Eisai.