Arena Pharmaceuticals Inc. appears to have made substantial progress addressing regulatory concerns about its potential obesity treatment, lorcaserin, according to a PiperJaffray analyst who said the drug could be approved by the middle of next year.
The Food and Drug Administration said last year that it would not approve lorcaserin because of limited evidence of its effectiveness and concerns about tumors when the drug was studied on rats. It asked for more data on the drug, and Arena met with the FDA last December to clarify the request.
The company has said it intends to resubmit the lorcaserin application around the end of this year, according to a Monday research note from analyst Edward A. Tenthoff.
Lorcaserin, being developed with Eisai Inc., is Arena’s most advanced clinical product and a major potential revenue producer.
Tenthoff said in the note that Arena has made “substantial progress” in addressing the FDA’s requests. He also said the Senate Appropriations Committee has directed the FDA to report on steps the agency is taking to support obesity drug development.
He also noted that the FDA has accepted a resubmitted application from Vivus Inc. for its potential weight-loss drug Qnexa, and Orexigen Therapeutics Inc. has agreed with regulators on the design of a study for another potential weight-loss drug.
“We believe these events represent a marked improvement in the regulatory environment for obesity drugs and see lorcaserin as the safest weight loss therapy for the majority of obese patients,” Tenthoff wrote.
The analyst upgraded his rating on Arena shares to “overweight” from “neutral.”
Date: November 28, 2011
Source: Associated Press