GENE ONLINE|News &
Opinion
Blog

2020-02-14| Manufacturing

Weight-Management Drug Belviq Withdraws from US Market

by GeneOnline
Share To

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

 

©www.geneonline.com All rights reserved. Collaborate with us: service@geneonlineasia.com
Related Post
Gene Therapy Innovations and Financial Challenges for the Future of Medicine
2024-06-12
ASCO 2024: Covering Skin Cancer, Bispecific Antibody Treatment, TIGIT-Targeted Drugs, Radiotherapy and More
2024-05-29
Major Cancer Research Publications at the 2024 American Society of Clinical Oncology Annual Meeting
2024-05-28
LATEST
Company Presentations at BIO 2024 Inspire Partnering
2024-06-14
GV Regains Compliance with Nasdaq Minimum Bid Price Requirement
2024-06-13
ARPA-H Fast-Tracks Biotech Startups: Funding Insights from BIO 2024 Panel
2024-06-12
Gene Therapy Innovations and Financial Challenges for the Future of Medicine
2024-06-12
BIO Releases DEI Survey in Partnership with Korn Ferry
2024-06-11
Advancing Healthcare Accessibility and Sustainable Development
2024-06-11
New CRISPR Method Enables Gene Edits in Cockroaches and All Insects
2024-06-11
EVENT
Scroll to Top