FDA Panel Backs Obesity Drug, Arena's Stocks Rise
U.S. Food and Health Administration panel’s recommendations to approve Arena’s Lorcaserin on Thursday sent the company’s stocks soaring.
According to reports, Arena’s stocks rose by almost 74 percent to $6.36 at 4 p.m. NY time.
Earlier this year competitor Vivus’s Qnexa had received a backing from FDA’s advisory panel. Orexigen Therapeutics’s Contrave too had received panel recommendation but was rejected by the agency. This is the second time that both Arena and Orexigen are waiting for a nod from FDA.
Lorcaserin was turned down in 2010 amid concerns about the drug’s side effects. Research on animal models had shown that the drug increased risk for brain tumors. Reports also say that the drug was associated with heart valve risk and even cancer.
The company had submitted additional data supporting the drug’s efficacy to the panel and won recommendation with a vote of 18 to 4 with one abstention on Thursday after the panel decided that the drug’s benefits outweighed the side-effects.
"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. We will continue to work with the FDA as the agency completes its review of the Lorcaserin new drug application,” said Jack Lief, Arena's President and Chief Executive Officer in a statement.
Obesity is increasing at a tremendous rate in America but the pill isn’t a magical cure-all remedy. The pill is to be taken along with healthy diet and exercise. Studies have shown that Lorcaserin use resulted in 5 % weight loss in 37 % of the study subjects. The average weight loss was at about 3.1 %. In general, FDA requires a 5% or more of weight loss to show that the pill is efficient.
The drug’s competitor Vivus’s Qnexa results in an average 11 % weight loss with over 80% of study subjects reporting a weight loss of 5%. Final decision on Vivus’s drug is expected around July 17.
The decision for Lorcaserin is reported to come by June 27. If approved, this drug would be the first one among the three drugs competing for FDA approval to hit the market. As of now only Xenical (alli) is approved for weight loss in U.S. the drug hasn’t gained popularity because of its side-effects like loose bowel movements, HealthPoP reports.