- The Food and Drug Administration has asked Japanese drugmaker Eisai to pull its weight loss pill from market after a large clinical trial found a higher frequency of cancer in patients who took it versus those who didn't.
- The post-marketing study was meant to evaluate how the pill, sold as Belviq, affects heart health. Results published in 2018 showed that, across 12,000 overweight or obese patients, the drug didn't appear to trigger cardiovascular benefits or risks more than placebo. However, the FDA reported Thursday a "range of cancer types," including colorectal, lung and pancreatic, were seen more often in Belviq-treated patients.
- Eisai has agreed to remove Belviq from the U.S. market, though the company noted that its interpretation of the study results is different than the FDA's. Eisai said it is "working closely with the Agency on the withdrawal process" and is talking to its global distribution partners about the withdrawal.
Belviq (lorcaserin) secured FDA approval in 2012, at a time when the pharmaceutical industry as well as investors saw immense opportunity in weight loss drugs.
Yet much of that opportunity failed to materialize. Though Belviq and other medications such as Contrave (naltrexone/bupropion) and Qsymia (phentermine/topiramate) did help patients lose weight, the amount was usually modest and sometimes hard to achieve because of side effects. The post-marketing study of Belviq, for example, showed patients taking the pill experienced headaches, fatigue and nausea, so much so that the number that dropped out of the trial was almost twice as high as the placebo group.
Doctors and payers ultimately found it hard to get onboard with using these medications, which in turn stifled the market. Arena Pharmaceuticals, which developed Belviq, ended up selling the full rights to Eisai in January 2017. A little more than a year later, Contrave developer Orexigen filed for Chapter 11 bankruptcy. Vivus, the maker of Qysmia, has a share price of around $2.60, far off the $285 seen in mid-2012.
In its most recent financial report, Eisai said Belviq revenue hit 4.6 billion yen (around $42 million) over the nine-month period from April 1 through Dec. 31, reflecting a year-over-year increase of nearly 14%. Belviq revenue in Eisai's Americas business was 3.1 billion yen for the period, up 4.2% year over year. Overall, Eisai recorded 486 billion yen over those nine months.
The FDA alerted the public in mid-January about the post-marketing Belviq study. At the time, the agency said it wasn't certain Belviq was contributing to the cancer risk. Now, it's recommending patients stop taking the drug and talk to health professionals about alternative weight-loss medicines and weight management programs.
Eisai shares were down more than 1% on both the Tokyo stock exchange and the OTC Markets exchange.