SAN DIEGO (AP) -- Arena Pharmaceuticals Inc. said Monday that European Union regulators have accepted its marketing application for lorcaserin, its experimental weight loss drug. Its shares climbed 30 percent to the highest level since 2010.
Arena did not say when it expects the European Medicines Agency to render a decision. The company said a panel of Food and Drug Administration advisers will review the drug on May 10.
The company is seeking approval to market lorcaserin for patients who are overweight or obese and have at least one health problem related to their weight. The drug's main ingredient is intended to stimulate serotonin receptors in the brain, making patients feel satisfied with what they have eaten.
The FDA refused to approve lorcaserin in October 2010 because the agency was not convinced it was effective, and was concerned about links to tumors when the drug was studied on rats.
Arena and its partner, Japanese drugmaker Eisai, have since sent more information about the drug to regulators. The FDA is scheduled to make a new ruling on the drug by June 27.
Arena's stock jumped 73 cents to $3.14 in afternoon trading. That's the highest level since September 2010 when the stock was falling from a peak of almost $8 a share. The stock fell sharply in 2010 after the Food and Drug Administration said lorcaserin produced minimal weight loss while raising concerns about heart damage, depression and other problems.
- Food and Drug Administration
- European Medicines Agency