The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee yesterday voted 9–5 against approval of Arena Pharmaceuticals’ (San Diego) appetite-curbing drug candidate lorcaserin hydrochloride. The panel believed that the risks outweigh the benefits of the drug for the treatment of obesity. Concerns focused on increased rates of depression and memory loss in patients as well as the presence of tumors in rats during early testing of lorcaserin.
“We believe that lorcaserin has a positive benefit-risk profile and represents a potential advance in the treatment of obesity,” Jack Lief, Arena’s president and CEO, said in a press release. “We will work with the FDA as the agency completes its review of the lorcaserin new drug application.”
FDA will decide by Oct. 22, 2010, on whether to approve lorcaserin. FDA is not required to follow the panel’s recommendations of drug approvals, but it usually does.
Another obesity-fighting drug, Qnexa (phentermine/topiramate) by Vivus (Mountain View, CA), is awaiting a decision on approval. FDA is scheduled to decide its status by Oct. 28, 2010. On July 15, 2010, the advisory committee voted against approving the drug because of safety risks.
And stay tuned for news about the next obesity drug to undergo scrutiny by the panel, Contrave (naltrexone SR/bupropion SR) by biopharmaceutical company Orexigen (La Jolla, CA). The panel will meet Dec. 7, 2010, and FDA will decide whether to approve it by Jan. 31, 2011. Orexigen recently formed a deal with Takeda (Osaka, Japan) for commercialization of the investigational drug.
On Wednesday, the same FDA committee met to discuss the safety of the drug Meridia (sibutramine, Abbott Laboratories, Abbott Park, IL), which was approved in the US in 1997. The panel’s 16 members were evenly split on whether to remove the drug from the market because of concerns stemming from the results of a clinical trial focused on cardiovascular side effects. Meridia is banned in Europe because of safety concerns based on the data from the same clinical trial. FDA will decide whether the drug will remain on the US market.
Abbott released a statement Wednesday, saying it will continue to work with FDA. “Today’s vote highlights the complexity of this scientific debate,” said Eugene Sun, MD, vice-president of global pharmaceutical development at Abbott. “We continue to believe that there are appropriate and identifiable patients that derive benefit from sibutramine.”
See related PharmTech articles:
More Japanese Interest in Potential Obesity Drugs (blog post)
FDA Mulls More Obesity Drugs (PharmTech)