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2020-02-14| Manufacturing

Weight-Management Drug Belviq Withdraws from US Market

by GeneOnline
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Japan’s Eisai Co Ltd. complies with the US Food and Drug Administration’s request to voluntarily withdraw its weight-loss drug, Belviq (Lorcaserin) from the US market. The decision for the agency’s request came after a follow-up analysis of CAMELLIA-TIMI 61 trial, a 5-year clinical trial involving 12,000 participants that assessed the safety of the drug.

The FDA’s risk-benefit assessment concluded that Belviq posed a higher risk to patients in developing cancer. It is reported that 7.7% (462) of patients who were taking 10 mg of Belviq twice a day were affected by more cancers as compared to 7.1% (423) in the placebo group. Pancreatic, colorectal, and lung cancers were some of the types diagnosed in those patients. The agency stated that there was little difference during the initial period, but the imbalance in the incidence of cancer grew over time.

Belviq was FDA approved in 2012, as an adjunct to a low-calorie diet and increased physical activity for chronic weight management in adults who are suffering from overweight or obesity-related medical issues. It achieved weight management by activating the serotonin receptor 5-HT2c in the hypothalamus to decrease appetite and prevent excess food intake.

Interestingly, the FDA did not find any increase in cardiovascular disease risk that the trial originally intended to evaluate. This is a fate that Eisai wouldn’t have anticipated when it acquired complete rights to develop and market Belviq from Arena Pharmaceuticals back in 2017. Though the long-term trial has revealed that Belviq causes cancer in patients, Eisai still claims that the difference is quite small and its “interpretation of the data from the CAMELLIA-TIMI 61 trial differs from that of the FDA”. However, the company is respecting the agency’s decision and is currently in talks with its global distribution partners to withdraw the product from the US.

Related reading: Eisai Partners with PGDx To Develop Liquid Biopsy NGS Tool Against Cancer

References

  1. https://www.prnewswire.com/news-releases/eisai-to-voluntarily-withdraw-belviqbelviq-xr-in-the-us-301004885.html
  2. https://www.drugs.com/belviq.html
  3. https://www.fda.gov/safety/medical-product-safety-information/belviq-belviq-xr-lorcaserin-eisai-drug-safety-communication-fda-requests-withdrawal-weight-loss-drug
  4. https://www.eisai.com/news/news201701.html

 

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