FDA advisory committee votes against approval for lorcaserin

Issue: October 2010

By a 9 to 5 vote, the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted against approval of lorcaserin as a weight-loss drug for obese patients. The committee cited concerns regarding potential risks of neoplasms and valvular heart disease associated with the drug.

Lorcaserin has been typically prescribed in patients with a BMI greater than 30 or a BMI of 27, and at least one obesity-related co-morbidity, such as hypertension, dyslipidemia, glucose intolerance, CVD and sleep apnea.

During the meeting, researchers presented data on a phase 3 trial that indicated a 5% weight loss in 47.5% of patients assigned lorcaserin (Lorqess, Arena Pharmaceuticals, Inc.) vs. 20.3% of patients assigned placebo.

Data from an additional phase 3 study indicated a 5% weight loss in 47.2% of patients assigned lorcaserin vs. only 25% of patients assigned placebo (P<.001 for lorcaserin 10 mg BID vs. placebo; P<.001 for lorcaserin 10 mg QD vs. placebo).

Allison B. Goldfine, MD, associate professor at Harvard Medical School, who voted for approval of the drug said, “This is a small magnitude of weight loss, but it can be clinically important.”

In its decision, the committee cited questions about the data regarding the effect of lorcaserin on valvular heart disease. According to FDA Briefing Documents, the RR of valvular heart disease in patients assigned lorcaserin was 1.07 (95% CI, 0.74-1.55). Other adverse events associated with use of the drug were a higher incidence for depression as well as cognitive adverse events, such as forgetfulness.

Along with recommendations for additional animal studies of neoplasms, the panel also suggested conducting clinical trials in patients with comorbid conditions, such as diabetes and CVD. These patients had been excluded from the phase 3 studies submitted to the FDA for review.

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