- Eisai's weight-loss drug Belviq did not increase cardiovascular risk versus placebo, according to results from a long-term Phase 4 clinical trial published Sunday in the New England Journal of Medicine.
- However, while the drug may not raise the risk of heart problems, it also didn't provide a statistically significant cardiovascular benefit across the study's 12,000 patients.
- The findings may raise the profile of the drug, but overall fits the trend of past results showing modest weight loss benefits alongside some side effects. The results were presented at a European Society of Cardiology meeting Sunday.
The study proves Belviq (lorcaserin) doesn't add to heart risks, fulfilling a post-marketing requirement imposed by the Food and Drug Administration following the drug's approval in 2012.
But the results also seem unlikely to significantly expand the market potential, as its impact on weight loss remains modest and side effects present a challenge.
With Belviq showing no higher heart risk after a median of 3.3 years, doctors probably won't rule out the drug, which needs to be prescribed in addition to a reduced-calorie diet and increased exercise. But it's uncertain whether the results will move doctors to seek it out, as it didn't reduce cardiovascular risk.
"For now, the drug may be best used on a cautious basis according to the needs of individual patients," concluded two NEJM editors in an editorial interpreting the study.
Belviq "was not associated with any increase in cardiovascular risk among patients at high cardiovascular risk," but didn't find any significant between-group differences in the total population, the study authors wrote.
"The experience with other weight-loss drugs has also been challenging owing to unacceptable safety profiles," the authors continued. "Indeed, no other specific lifestyle or pharmacologic weight-loss strategy has yet to result in a reduction in cardiovascular effects."
The large study did provide additional data showing modest improvement in weight loss along with lifestyle changes, with net mean weight loss of 2.7% after one year. The study found the drug "more than tripled the odds of having a weight loss of at least 5% or at least 10% as compared with placebo."
Patients experienced side effects such as headaches, fatigue, dizziness and nausea at a prevalence that led to nearly twice the number of discontinuations as placebo, although the number of reported serious adverse events was roughly the same between the groups.
When several weight loss drugs entered the U.S. market, sales expectations were high due to the robust patient population for such therapies. Three biotechs — Arena, Orexigen and Vivus — rode that optimism to FDA approvals.
Arena was the first to win an FDA OK with Belviq in 2012. It sold the drug to Eisai in January 2017. Belviq posted net sales in North America of $34 million in 2016 and $32 million last year, according to a company report. (It is only directly marketed in the U.S.).
While Eisai forecasted a 12% bump in sales for 2018 in local currencies in the Americas, first quarter results released Aug. 1 showed $9 million.
Orexigen's Contrave (naltrexone/bupropion) was granted FDA approval in 2014. The company declared Chapter 11 bankruptcy this March, roughly two years since Japanese pharma Takeda bailed on a marketing partnership. It sold Contrave on July 30 to a special purpose vehicle of Pernix Therapeutics for $73.5 million.
Vivus, meanwhile, has Qsymia (phentermine/topiramate), which was approved in July 2012. It posted net revenues of about $45 million last year, down from $48.5 million in 2016 and $54.6 million in 2015, as the number of prescriptions dispensed fell by about 30% from 2015 to 2017, according to a company SEC filing.
Vivus, which had a share price north of $28 and a market cap of $2.85 billion in a mid-2012 peak, now trades well below $1 per share on the Nasdaq with a company value of roughly $60 million.