Eisai said Thursday that it will voluntarily withdraw and discontinue sales of Belviq (lorcaserin) and Belviq XR in the US. The move comes at the request of the FDA, which determined based on a completed analysis of data from the CAMELLIA-TIMI 61 trial that the potential increased risk of cancer associated with Belviq outweighs the drug's benefits. It has also advised doctors to stop prescribing the anti-obesity therapy.
The Japanese drugmaker stated that its "interpretation of the data from the CAMELLIA-TIMI 61 trial differs from that of the FDA," although it "respects the FDA's decision and is working closely with the agency on the withdrawal process." The company had applied to the FDA last year to include long-term efficacy and safety data from CAMELLIA-TIMI 61 on Belviq's label.
Belviq was approved by the FDA in 2012 to help with chronic weight management in obese adults who have a body mass index (BMI) of at least 30, or in overweight adults with a BMI of 27 or more who have at least one weight-related co-morbid condition. At the time of approval, Eisai was required to conduct a long-term trial evaluating the cardiovascular (CV) effects associated with use of the weight-loss drug. The randomised, placebo-controlled CAMELLIA-TIMI 61 study followed about 12,000 men and women over a five-year period who have established CV disease or are at high risk for CV disease.
Based on a preliminary analysis of the data, the FDA issued a warning last month that the CAMELLIA-TIMI 61study showed a possible increased risk of cancer with Belviq and Belviq XR. At the time, the FDA said "the cause of the cancer is uncertain, and we cannot conclude that [the drug] contributes to the cancer risk."
On Thursday, the agency said its completed review uncovered a "numerical imbalance" in the number of patients with malignancies, with one additional cancer observed per 470 patients treated for one year. Specifically, 7.7% of patients treated with Belviq in the trial were diagnosed with 520 primary cancers, compared to 7.1% of patients in the placebo group who were diagnosed with 470 cancers. "Imbalances in specific cancers including pancreatic, colorectal and lung contributed to the observed overall imbalance in cancer cases," the FDA noted, adding that the gap between the groups increased the longer patients were on the drug. Meanwhile, the primary safety analysis showed "no meaningful difference" between Belviq and placebo in the risk of major adverse CV events.
Eisai stated that its assessment is that Belviq and Belviq XR "continue to have a positive benefit-risk profile in the patient population for which they are indicated." The drugmaker said it is now in discussions with its global distribution partners regarding the matter. In its most recent earnings presentations late last month, Eisai said Belviq generated third-quarter sales of JPY 1.4 billion ($13 million), which was down from JPY 2 billion ($18 million) in the year-ago period.
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