May 11, 2012
New Anti-Obesity Drug Approved By Expert Panel
A panel voted 18 to 4 in favor of approving the new anti-obesity drug Lorcaserin for use on the drug market.
The drug works to control the appetite through receptors in the brain, and a study showed it helped nearly half of participants lose up to five percent of their body weight.The Food and Drug Administration is scheduled to decide on June 27 whether the drug should be approved for use in the U.S.
Lorcaserin was rejected by the Endocrinologic and Metabolic Drugs Advisory Committee back in 2010 due to concerns that it formed breast tumors in rats.
However, the effects seen in that study did not appear in trials on overweight and obese humans, and the panel's latest vote showed confidence that its benefits outweigh the risks.
"The advisory committee's positive vote supports our belief in Lorcaserin as a potential new treatment option for the medical management of overweight and obesity," Jack Lief, Arena's president and chief executive officer, said in a statement.
"We will continue to work with the FDA as the agency completes its review of the lorcaserin new drug application."
The most common side effect for those taking a 10 milligram dose of Lorcaserin were headaches, dizziness, nausea, fatigue and dry mouth.
"It is not very impressive, the weight loss, but it is better than a placebo," Michael Aziz, an internist at Lenox Hill Hospital in New York City, said in a statement. "However, when people stop the drug they gain the weight back."
According to the U.S. Centers for Disease Control and Prevention, about two-thirds of adults in this country are overweight or obese.
"There is a need for a drug that can address the obesity issue," Aziz added. "But we are really not covering the root of the problem which is lifestyle changes and eating right. Many people are just looking for a quick fix."
Currently, there are few weight-loss drugs approved in the U.S. Xenical, one drug approved, works by preventing the body from absorbing fat, but it has a tenancy to cause gastrointestinal side effects like oily, loose stools.
FDA advisors also urged the approval of Qnexa back in February, which is a decision expected to be made in mid-July as well. Studies have shown dieters could lose up to 10 percent of their weight when taking Qnexa, along with regular exercise and following a healthy diet.
If Lorcaserin is approved, an Arena spokeswoman said the Japanese pharmaceutical company Eisai has a U.S. division with exclusive rights to commercialize it in the U.S.
Shares of Arena Pharmaceuticals, the maker of the pill, nearly doubled in value after the panel's decision. Arena's stock price rose 70 percent to $6.17 in morning trade on the NASDAQ.
On the Net:
- U.S. Food and Drug Administration (FDA)
- U.S. Centers for Disease Control and Prevention
- Lenox Hill Hospital
- Arena Pharmaceuticals