Obesity Drug Not Approved by FDA
Obesity Drug Not Approved by FDA
Obesity Drug Not Approved by FDA
Post by (Chanel Taschen) Oct 2010
The U.S. Food and Drug Administration declined to approve Arena Pharmaceuticals Inc.'s obesity drug lorcaserin, raising questions about the drug's effectiveness and seeking more information about its cancer risk.
The San Diego company, developing the drug with Eisai Co., said Saturday that it expects to meet with the FDA within the next few weeks to clarify the agency's requests.
"We intend to meet with the FDA to obtain further clarity on the approval path and timeline," said Jack Lief, Arena's president and chief executive. "We will work with the agency to address the issues with our [new drug application] as quickly as possible."
The FDA's rejection again shows how high the regulatory bar is for obesity drugs. Arena is in a three-way race with Orexigen Therapeutics Inc. and Vivus Inc. to sell a new weight-loss pill. Vivus' Qnexa was rejected by an FDA panel in July and should get a decision from the larger FDA this week. Orexigen's Contrave goes before an FDA panel in December.
The FDA, in its complete response letter to Arena, said the weight-loss efficacy of lorcaserin in overweight and obese individuals without type 2 diabetes was marginal. The agency recommended that Arena submit the final report on a trial that evaluates lorcaserin versus a placebo, or fake drug, over a one-year treatment period in obese and overweight patients with type 2 diabetes.
The trial is complete, Arena said, and the company expects to announce results in the next few weeks and to have a completed study report by the end of the year.
Lorcaserin met only one of the FDA's two standards for weight loss. The agency requires that the difference in the average weight loss be at least 5% between patients being treated with the active drug compared to the placebo. The FDA said the average weight loss with lorcaserin was about 3% greater than the average weight loss for patients given a placebo.
The FDA also asked for more information about the development of breast tumors in female rats when given a higher dose than would be used in humans. There was no imbalance in the incidence of cancer in human studies.
The agency said that if Arena can't provide enough evidence to ease its cancer concerns, then the company may have to conduct additional studies. If Arena has to do further trials, it could significantly delay any FDA approval.
Arena shares plunged in September after FDA documents revealed the cancer risk and the agency's panel rejected the drug. The stock, which hit a 52-week high of $8 this summer, rose 12% Friday to $1.67 on optimism ahead of the FDA's final decision.
The company will hold a conference call Monday to discuss the situation.
Obesity has been a difficult field for drug companies because the side effects of any drug need to be minimal due to potential long-term use by otherwise healthy patients. The current batch of obesity drugs being reviewed by the FDA, including those from Vivus and Orexigen, work by affecting the patient's central nervous system to quell appetite.
The federal Centers for Disease Control and Prevention estimates that two-thirds of U.S. adults are overweight, with a third of those obese. Obesity involves a measure of weight in relation to height and is defined as having a body mass index that is 30 or higher. The medical costs due to obesity were estimated at $147 billion in 2008, according to a study in the journal Health Affairs last year.
Although the need is high, the area has been plagued with multiple disappointments, tough regulators and lackluster sales. No new treatments have been approved since 1999 in the U.S.Wenn Sie an Chanel Taschen interessiert sind,bitte besuchen unsere Website:Chanel Taschen
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