In a bid to help Americans lose weight, the Food and Drug Administration has approved marketing of the drug lorcaserin, the first prescription medication to have won the FDA’s blessing since it approved orlistat in 1999.
Once it is cleared by the Drug Enforcement Administration, the new weight-loss drug will be marketed in the United States under the commercial name Belviq.
The approval comes after a lengthy review by an agency under pressure to help Americans lose weight but also to screen out drugs that could prove dangerous once embraced by a vast patient population.
Just over one in three adult Americans is considered obese, and an additional 36% are overweight, prompting widespread concern that Type 2 diabetes, heart disease and certain cancers linked to obesity will overwhelm the U.S. healthcare system. Already, obesity-related disease is estimated to account for $147 billion in annual healthcare costs.
Belviq, made by San Diego-based Arena Pharmaceuticals, is the first of four candidate weight-loss drugs the FDA has anguished over in recent years. Concerns over safety have prompted the agency to order the makers of two other candidate drugs to conduct and comb through more research. A third drug was withdrawn after it was linked to elevated suicide risk.
And in the 28 months since the makers of Belviq submitted the drug for FDA consideration, the agency also demanded the withdrawal of Meridia, one of only two prescription weight-loss drugs still on the market, after studies showed it increased the risk of heart attack and stroke.
The result has been — to the growing frustration of many obesity experts — almost no pharmaceutical aid for a steadily growing population of Americans desperate for help in shedding pounds.
Belviq offers would-be dieters modest benefits. A clinical trial of lorcaserin published in the New England Journal of Medicine found that two-thirds of patients on the drug lost 5% of their body weight, while a third lost at least 10%, after one year taking the drug as a supplement to diet and exercise.
Subjects’ average weight loss was 17 to 18 pounds.