Diet Pill Lorcaserin Gets Thumbs-Down from FDA
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(CBS/AP) Hope for a new prescription weight-loss pill bit the dust over the weekend when the FDA rejected lorcaserin, calling any weight loss the drug produces in overweight people without diabetes "marginal."
The FDA also cited concerns about tumors that developed in rats during early stage testing.
Lorcaserin is part of a new wave of weight loss drugs seeking FDA approval. In July, an FDA advisory panel voted against approval for a drug called Qnexa after studies showed signs of heart palpitation and suicidal thoughts.
If lorcaserin had been approved, it would have been the first new prescription weight loss drug in more than a decade. In 1997 Wyeth's diet pill combination fen-phen was pulled from the market because of links to heart valve disease.
Lorcaserin's backers have argued that it offers a safer way to shed pounds than older medications linked to dangerous side effects. Its maker, Arena Pharmaceuticals Inc, hasn't given up yet.
The company plans to request a meeting with the FDA "to obtain further clarity on the approval path and timeline," Arena president and CEO Jack Lief said in a news release.
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It seems to me when the FDA says the pill doesn't do anything, it's not going to get approved. This means the FDA doesn't have a time-line and the approval path requires a drug that, oh, I don't know... How about a drug that actually works?
The whole time-line and path is back in the drug company's court. Once they produce a safe weight-loss drug that works, they'll get approved. How long that will take is up to them.
But for this drug, there's nothing to clarify. The FDA has already spoken.