Belviq
Manufacturer
Arena Pharmaceuticals $2.71 Billion
Eisai* $23.99 Billion
Belviq
Belviq XR
*Eisai is responsible for the marketing and distribution of BELVIQ in the United States under its agreement with Arena Pharmaceuticals.
FDA Approval
Belviq NDA 022529 June 27, 2012
Belviq XR NDA 208524 July 15, 2016
Generics None
MDL Information
No information at this time
Background
Belviq (lorcaserin) was approved by the FDA in 2012. Belviq is used together with diet and exercise to treat chronic obesity and obesity with underlying conditions.
Belviq is a serotonin 2C receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of: 30 kg/m2 or greater (obese) OR, 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition, (e.g., hypertension, dyslipidemia, type 2 diabetes).
The FDA rejected Belviq in 2010 because of unanswered questions about cardiovascular side effects and the drug’s propensity to cause cancer in rats. To allay the FDA’s cardiovascular concerns, Belviq’s manufacturer, Arena Pharmaceuticals, sponsored huge trials in which thousands of patients taking Belviq, or a placebo, received regular echocardiograms to see if the drug was harming their valves. The FDA panel concluded Belviq was safe enough to go on the market, but recommended an extensive post-marketing study to rule out cardiovascular complications.
The European Medicines Agency was so concerned about the drug's safety that it rejected the drug. The drug's manufacturer, Arena Pharmaceuticals, recently (2013) withdrew its application for the drug's use in Europe.
Treatment / Use
Belviq is used together with diet and exercise to treat chronic obesity and obesity with underlying conditions.
The regular tablet is usually taken 2 times per day. The extended-release tablet is taken only once per day. Follow your doctor's instructions.
Do not crush, chew, or break an extended-release tablet. Swallow it whole.
You may take Belviq with or without food.
You should lose at least 5% of your starting weight during the first 12 weeks of taking Belviq and eating a low calorie diet. Call your doctor if you do not lose at least 5% of your starting weight after taking the medicine for 12 weeks.
Injuries / Complications / Concerns
Following its review of the data, FDA concluded that the potential risks of lorcaserin outweigh its benefits. More specifically FDA noted there was a numerical imbalance in the number of patients with malignancies. FDA's analysis of the study found that during the course of the trial, 462 (7.7 percent) patients treated with lorcaserin were diagnosed with cancers compared to the placebo group, in which 423 (7.1 percent) patients were diagnosed with cancers.
There was a range of cancers, with pancreatic, colorectal and lung cancer reported more often in the patients who took Belviq, the FDA said. The agency said no special cancer screening is needed for anyone who took Belviq. It noted the increased risk was only seen after extended use of the drug.
Information on the Topic of Belviq
Eisai Withdrawal Announcement on WWW.Belviq.com (2-16-2020)
Belviq, Belviq XR Withdrawn from US Market (2-14-2020)
https://www.empr.com/home/news/belviq-belviq-xr-withdrawn-from-us-market/
Weight Loss Drug Belviq Pulled from Market Over 'Slight' Cancer Risk (2-14-2020)
https://time.com/5784701/belviq-pulled-market-cancer-risk/
FDA Drug Safety Communication: FDA Requests the Withdrawal of the Weight-Loss Drug Belviq, Belviq XR (Lorcaserin) from the Market (2-13-2020)
https://www.fda.gov/media/135189/download
Eisai to Voluntarily Withdraw Belviq / Belviq XR in the U.S. (2-13-2020)
FDA Asks that Weight Loss Drug Belviq be Pulled from the Market (2-13-2020)
https://www.fool.com/investing/2020/02/13/fda-asks-that-weight-loss-drug-belviq-be-pulled-fr.aspx
Belviq Approval History (2-3-2020)
https://www.drugs.com/history/belviq.html
CV Safety Trial for Lorcaserin (Belviq) Picks up Cancer Signal: FDA (1-14-2020)
https://www.tctmd.com/news/cv-safety-trial-lorcaserin-picks-cancer-signal-fda
Weight-Loss Drug Belviq may Carry Cancer Risk, FDA Warns (1-14-2020)
FDA: Weight Loss Drug Possibly Linked to Cancer (1-15-2020)
https://www.empr.com/home/news/fda-weight-loss-drug-possibly-linked-to-cancer/
A Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects With Cardiovascular Disease or Multiple Cardiovascular Risk Factors (CAMELLIA-TIMI) (7-16-2019)
https://clinicaltrials.gov/ct2/show/NCT02019264
Safety Clinical Trial Shows Possible Increased Risk of Cancer with Weight-Loss Medicine Belviq, Belviq XR (Lorcaserin) (1-14-2019)
U.S. FDA Approves Belviq XR, A Once-Daily Formulation of Lorcaserin for Chronic Weight Management (7-19-2016)
https://www.eisai.com/news/news201652.html
FDA Approval Package: Belviq XR (Lorcaserin Hydrochloride) Extended-Release Tablets (7-15-2016)
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208524Orig1s000TOC.cfm
Arena Pharmaceuticals Reports That Eisai Will Double BELVIQ® (lorcaserin HCl) CIV Sales Force by December (10-15-2013)
Weight-Loss Pill Belviq is Now Available, but We Say Skip It (6-13-2013)
Fen-Phen All Over Again? (7-3-2012)
FDA Approval Package: Belviq (Lorcaserin Hydrochloride) Tablets (6-27-2012)
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022529Orig1s000TOC.cfm
Belviq Highlights of Prescribing Information (6-2012)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022529lbl.pdf