October 23, 2010
No F.D.A. Approval for New Diet Pill
By ANDREW POLLACK

The Food and Drug Administration has declined to approve what would have been the first new prescription diet pill in more than a decade.

The agency’s rejection of the drug, called lorcaserin, was announced late Friday by the drug’s developer, Arena Pharmaceuticals, and its marketing partner, Eisai.

The rejection was not a surprise because an advisory committee to the F.D.A. had voted 9 to 5 against approval in September.

Nevertheless, it is the latest setback to efforts to develop a medical treatment for obesity, which is considered one of the nation’s costliest medical problems. About one-third of American adults are obese and another third are overweight, and their weight contributes to health problems like diabetes and heart disease.

But obesity drugs often run into safety problems or produce only small losses in weight.

Earlier this month, the F.D.A. pressured Abbott Laboratories to take its diet drug Meridia off the market after a study found that it raised the risks of heart attacks and strokes in certain patients. In 1997, part of the fen-phen diet pill combination was removed from the market for damaging heart valves.

In rejecting lorcaserin, the F.D.A. said, in essence, that safety concerns outweighed what the agency called the drug’s “marginal” effectiveness in causing people to shed pounds, according to the press release from Arena and Eisai.

The biggest issue was that the drug in high doses caused tumor formation in rats. According to the companies, the F.D.A. asked for an independent review of the animal data and possibly new studies to establish that the animal findings were not relevant to people.

If the concerns cannot be alleviated, more clinical trials involving patients may be required. However, a spokesman for Arena said the company was confident it could address the issues with animal data alone. How long this will take was not clear, he said, since the company has yet to meet with the agency.

The F.D.A. itself does not comment on the reasons it rejects a drug or what new studies it requests from a company.

In clinical trials, those taking lorcaserin lost an average of 5.8 percent of their weight after a year, compared to 2.5 percent for those taking a placebo. The F.D.A. told the companies it wanted to see the results, expected by the end of this year, from a trial testing the drug in overweight and obese people with Type 2 diabetes.

Some investors in Arena waged an unusual campaign to get the drug approved. About 100 people wrote letters or e-mails to the F.D.A. urging the drug’s approval, according to an agency spokeswoman.

Such campaigns may become more common. The fate of many small biotech companies, and the price of their stock, often rides on a single drug.

Investors had also protested the agency’s rejection in 2007 of Provenge, a prostate cancer treatment developed by Dendreon. This year, after a new clinical trial confirmed the previous results, the agency approved Provenge.

In the case of lorcaserin, the investors said in an online petition that garnered about 2,000 signatures that the F.D.A. had made “misinterpretations and misrepresentations” of the rat data, thereby causing the advisory committee to vote against approval.

They said the agency had overstated the seriousness of the rat data by combining malignant and non-malignant tumors. They also complained that despite the centrality of that issue, there was no animal toxicologist on the advisory committee.

In a reply sent to these people, the F.D.A. said that “in hindsight,” it “regrets that no toxicologist participated in the meeting.” But it said toxicologists on the agency’s staff had reviewed the data.

James Stevens, a retired computer industry executive in Carlsbad, Calif., who is a member of the investor group, said in an e-mail on Saturday morning that he was “elated” that the F.D.A. was calling for what his group had been seeking — an independent review of the rat data.

Jack Lief, the chief executive of Arena, which is based in San Diego, said in a statement that the F.D.A.’s letter was “an important step for us toward F.D.A’s approval of lorcaserin.” Lonnel Coats, chief executive of Eisai Inc., the American subsidiary of the Japanese drug company, said Eisai was “committed to collaborating with Arena to address the F.D.A.’s requests.”

The F.D.A. is expected to decide later this month whether to approve another obesity drug, Qnexa, developed by Vivus.

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