FDA Approves First Rx Weight-Loss Drug in More Than a Decade
On Wednesday, FDA for the first time in 13 years granted market approval to a new prescription weight-loss drug, the New York Times reports (Pollack, New York Times, 6/27).
About the Drug
The new drug, lorcaserin, was developed by San Diego-based Arena Pharmaceuticals and will be sold under the name Belviq (Healy, "Booster Shots," Los Angeles Times, 6/27).
Lorcaserin has been approved primarily for:
- Obese adults, who have a body mass index of 30 or higher; or
- Overweight adults, who have a BMI of 27, or greater, and who have at least one weight-related health condition, such as hypertension, type 2 diabetes or high cholesterol (Robbins, U-T San Diego, 6/27).
- FDA officials said the drug should be used as part of a weight-management plan that includes regular exercise and a reduced calorie diet (Corbett Dooren, Wall Street Journal, 6/27).
FDA in 2010 rejected lorcaserin over safety and efficacy concerns, but an agency advisory committee in May recommended approval based on new data.
Although some advisory panel members expressed disappointment with the drug's modest weight-loss benefits, most agreed that the drug's benefits outweigh its shortcomings, particularly because overweight and obese patients currently have limited options. In approving lorcaserin this week, FDA agreed with that assessment, according to U-T San Diego.
Acknowledging some advisory panel members' concerns about potential heart valve problems, FDA said Belviq "does not appear to activate" a chemical pathway that was tied to cardiovascular problems from another weight-loss combination drug known as fen-phen.
As part of the approval, FDA is requiring Arena to conduct six postmarket studies of lorcaserin, including a long-term study to determine whether the drug increases risk of heart attack and stroke (U-T San Diego, 6/27). According to the Wall Street Journal, the drug also will undergo a four-to-six month process at the Drug Enforcement Agency for a scheduling classification, which is required for drugs that have the potential for misuse (Wall Street Journal, 6/27).
Arena officials said it is unclear when the drug will be introduced to the market or what it might cost patients (New York Times, 6/27).
FDA last approved a major weight-loss drug in 1999 -- Roche's Xenical -- and the agency on July 17 is expected to decide whether to grant approval to another drug by Vivus, called Qnexa (U-T San Diego, 6/27).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.