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FDA Seeks Data on Arena Obesity Drug

The Wall Street Journal

OCTOBER 24, 2010

FDA Seeks Data on Arena Obesity Drug, Setting High Bar


The Food and Drug Administration said it cannot approve the obesity drug lorcaserin from Arena Pharmaceuticals Inc. because of potential safety risks and data showing the drug has a “minimal” effect on weight loss.

Arena, backed by a vocal group of investors, said it believes the drug still can be brought to market once the company supplies more data to the FDA.

But the FDA move again shows how high the regulatory bar is for obesity drugs. Another weight-loss pill, Vivus Inc.’s Qnexa, was rejected by an FDA advisory panel in July over concerns about long-term safety and is due for a decision by the FDA this week.

In early October, Abbott Laboratories pulled the appetite suppressant Meridia from the market at the FDA’s request. The agency cited concerns that the drug, first approved in 1997, could lead to heart attacks or strokes.

An FDA letter to Arena discussed the need for more positive data on lorcaserin’s long-term efficacy and concerns about an early study on rats that showed breast-tumor growth among the females, the company said.

“This is an important step for us toward the FDA’s approval of lorcaserin,” said Jack Lief, Arena’s chief executive. He added, “We will work with the agency to address the issues.”

The FDA wants Arena to hire an independent pathologist to re-evaluate the company’s data on the rat tumors. No study showed tumor growth in humans. If the review isn’t conclusive, the FDA could request more studies.

The FDA letter said that the current weight-loss data didn’t include diabetes patients. Arena will have initial results of a one-year weight-loss trial involving patients with Type 2 diabetes in a few weeks and will give full information to the FDA by the end of the year, the company said.

Some investors said they will continue to push for FDA approval of lorcaserin.

Shareholders have been conducting an unusually aggressive lobbying campaign to get Congress to intervene and urge FDA officials to approve the drug. The investors’ activism surged after an FDA advisory committee voted down the drug 9-5 in September, citing modest efficacy. Arena stock lost 73% of its value that September week.

The investors have been conducting their own detailed research on lorcaserin and have flooded the FDA with messages saying that the rat study was misinterpreted and the weight loss is more significant than the advisory panel judged. Arena says it isn’t involved in the investor campaign.

One shareholder, Ardeis Scott, said the FDA’s letter was a “fair response.” Dr. Scott, an emergency-medicine doctor in the Tampa Bay, Fla., area, added: “I have to feel the public outcry by investor groups played a significant role.”

Other observers were less sanguine. “The drug is delayed many years, if I had to guess, because of the safety issues and lack of good efficacy results,” said pharmaceutical-industry analyst Steven Greer of The Healthcare Channel video site.

The FDA didn’t release its letter to Arena and declined to comment on the letter’s contents. The company was set to hold a conference call Monday.

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. Lorcaserin, like other obesity drugs before the FDA, works by affecting the patient’s central nervous system to quell appetite.

Although the spread of obesity means the need is high, the area has been plagued with multiple disappointments and lackluster sales. No new treatments have been approved since 1999 in the U.S.

Write to Alicia Mundy at and George Stahl at

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