Arena Pharmaceuticals Inc. rose as much as 26 percent after the U.S. Food and Drug Administration said it “regrets” the lack of an animal toxicity expert on an advisory panel that rebuffed the obesity drug lorcaserin.
“In hindsight, FDA regrets that no toxicologist participated in the meeting,” the agency said yesterday in a letter to Arena shareholders who had complained about the Sept. 16 meeting.Karen Riley, an agency spokeswoman, provided a copy of the letter today in an e-mail.
Lorcaserin, licensed by Tokyo-based Eisai Co., would be San Diego-based Arena’s first product. The companies are vying with Vivus Inc. and Orexigen Therapeutics Inc. to introduce the first prescription weight-loss drug in more than a decade.
The agency’s letter may provide optimism to investors that the FDA “isn’t blindly wanting to reject the drug,” Jon Lecroy, an analyst at Hapoalim Securities in New York, said today in a telephone interview. “They’re trying to do a balanced review of all the data,” he said.
Last month’s FDA advisory panel said in a 9-5 vote that the drug doesn’t work well enough to justify risks over time in overweight and obese patients.
Arena gained 21 cents to $1.67 at 2:45 p.m. New York time in Nasdaq Stock Market trading, after climbing as high as $1.84. Forbes reported on the letter earlier today.
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