FDAnews Drug Daily Bulletin

Arena’s Belviq Avoids a REMS, But Saddled With Six Postmarket Studies

July 6, 2012
The FDA has approved its first weight-loss drug in 13 years, giving the OK to Arena Pharmaceutical’s Belviq, while requiring a hefty dose of postmarket studies on cardiovascular events. Arena must conduct six postmarket studies, including five in different pediatric age ranges. The FDA is also mandating a long-term cardiovascular outcomes trial that will finish in 2018. The company hopes to start this study by mid-2013.
Washington Drug Letter