Please ensure Javascript is enabled for purposes of website accessibility

FDA Asks That Weight Loss Drug Belviq Be Pulled From the Market

By Brian Orelli, PhD - Updated Feb 13, 2020 at 6:34PM

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

A study finds an increased risk of cancer, and the manufacturer complies with the FDA's request.

The Food and Drug Administration has asked Tokyo-based Eisai (ESALF 0.18%) to withdraw its weight-loss drugs Belviq and the extended release formulation, Belviq XR, from the U.S. market. The Japanese drugmaker reluctantly complied, submitting a request to voluntarily withdraw the drug.

When the drug was approved in 2012, the FDA required Eisai and its partner Arena Pharmaceuticals (ARNA) to run a clinical trial to test for the risk of cardiovascular problems. It turns out the study found that patients taking Belviq had a higher incidence of cancer (including pancreatic, colorectal, and lung cancer) than those who received placebo.

The difference wasn't that great: 7.7% for patients taking Belviq compared with 7.1% for those taking placebo. Eisai thinks the weight-loss benefit outweighs the potential increase in cancer risk, but the pharmaceutical company decided not to put up a fight (presumably for fear of repercussions from the agency on other approvals) and will withdraw the drug.

The low global sales of Belviq -- just 3.0 billion yen ($27.3 million) through the first nine months of Eisai's fiscal year -- likely influenced the company's decision to not fight with the agency.

Legs stepping onto a scale

Image source: Getty Images.

The FDA is recommending that patients stop taking the medication and dispose of it. Doctors will need to stop prescribing the drug and are expected to contact their patients to ask them to stop taking it.

Eisai licensed rights to market Belviq in the U.S. from Arena Pharmaceuticals in 2010 for $50 million up front, as much as $90 million if the drug was approved, and $1.2 billion in potential sales milestones. A few years after the approval, in 2017, the companies amended their agreement, with Eisai taking over all of the marketing of the drugs.

Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

Arena Pharmaceuticals, Inc. Stock Quote
Arena Pharmaceuticals, Inc.
ARNA
Eisai Co., Ltd. Stock Quote
Eisai Co., Ltd.
ESALF
$42.83 (0.18%) $0.08

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning service.

Stock Advisor Returns
330%
 
S&P 500 Returns
115%

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 05/21/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.