SAN DIEGO (
) -- Is
in danger of getting "Meridiacked"?
It's possible if this scenario sounds familiar: A panel of independent experts is brought to a suburban Washington, D.C. hotel meeting room by the U.S. Food and Drug Administration and asked to decide whether or not to yank a controversial drug from the market because of safety data tying the drug to an increased risk of heart attack and strokes.
The next day, this same weary panel of experts -- reminded of what happens when unsafe or ineffective drugs receive FDA approval -- returns to the hotel meeting room and sits in judgment of a new weight-loss drug.
learned all too well that this setup can lead to a bad outcome. Last month, the company's
by an FDA advisory panel that had spent the previous two days arguing over the heart safety of
diabetes drug Avandia.
FDA officials must have a keen sense for the dramatic because they've set up a repeat of this scenario for September.
The same FDA advisory panel is reconvening Sept. 15 to hash out data that ties
currently marketed obesity drug Meridia to an increased risk of heart attacks and strokes. The following day, Sept. 16, the panel will review the efficacy and safety of Arena's experimental weight-loss drug lorcaserin.
Déjà vu? If so, it's "uh oh" for Arena.
Arena's apparent advantage, so far, is that lorcaserin does not appear to have any of the safety baggage, cardiovascular or otherwise, that has weighed on Avandia, Meridia and Qnexa.
Phase III studies of lorcaserin have come back with a clean safety sheet, including checks of patients' heart valves, a precaution made necessary because lorcaserin is related chemically to fenfluramine, the old weight-loss drug (part of the fen-phen combination) that FDA yanked from the market for causing heart valve damage.
And where Vivus had one year's worth of safety data for the cantankerous FDA panel to review, Arena has two years of safety data. We'll soon see if that's enough to satisfy the FDA's outside experts.
"The Meridia discussion is likely to create an unfavorable atmosphere for the discussion of Arena's application. Arena, however, has an important advantage in that the sponsor has seen how the advisory committee can come in hyper-sensitized to the challenge of forecasting and predicting potential safety issues from the previous day's discussion," said Concept Capital's Washington Research Group, in a report issued Friday.
Arena's bigger worry might just be that
lorcaserin doesn't really help patient lose much weight
. The two phase III studies of lorcaserin conducted by Arena barely managed to clear the weight-loss standards set by FDA for experimental obesity drugs.
FDA panel members, fresh from spending the day discussing Meridia, may be surprised to learn that lorcaserin's weight-loss efficacy is no better, or even slightly less, than Meridia, as was pointed out in a recent editorial about lorcaserin's phase III data published in the
New England Journal of Medicine
If the FDA panel discussion does veer towards safety, it may focus on the lack of any data showing that lorcaserin can be combined safely with phentermine (the "phen" in fen-phen and still a commonly used weight loss drug prescribed by doctors.)
A "lor-phen" combination might be the ticket to more meaningful weight loss for patients, but can it avoid the heart-damaging side effects of the old fen-phen? No one knows for sure because Arena didn't study the two drugs together.
In July, the FDA advisory panel kicked Vivus' Qnexa to the curb, in part, because of a theoretical safety risk that couldn't be proven or disproved due to a paucity of data.
Again, Concept Capital: "After a day of discussing the cardiovascular effects from use of Meridia, the advisory committee is very likely to want to focus on real-world predictions about use of the new obesity agent and how it might interact with current treatment regimens for weight-loss or other drugs in the marketplace for weight-loss or used by likely patients...
"Arena appears to have gotten that message. Whether the sponsor will have sufficient time to anticipate and design a sufficient post-marketing plan before September 16 is a key question to the outcome of the advisory committee review."
Arena shares have doubled in price since mid-July when the FDA panel dinged Vivus' Qnexa, hotting $8 a share late last month.
The stock closed Friday at $7.16 Investors seem confident, perhaps overly so, that lorcaserin will not run into any problems and will be approved by the FDA's approval decision date of Oct. 22.
The outcome of the two-day FDA panel on Sept. 15-16, will largely determine lorcaserin's fate.
-- Reported by Adam Feuerstein in Boston.
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