A Muted Win For Avandia Manufacturer—But Stay Tuned…

July 15th, 2010. By Hunter West

So Avandia has been stayed from execution—for now—by virtue of a majority vote by an expert panel of experts brought together by the US Food and Drug Administration (FDA) that debated the drug’s safety and efficacy for two days this week. The Type 2 diabetes drug that has been under much fire for the past couple of years was further challenged by the long-awaited gathering which ended with a vote to leave Avandia, manufactured by GlaxoSmithKline (Glaxo), on the market for the time being.

But the victory for Glaxo is muted.

While the panel voted 20-12 to leave Avandia on the market, it will not likely be left alone. That’s because at least half of those voting ‘yay,’ according to the July 14^th edition of the Wall Street Journal (WSJ), tied their vote of support to increased restrictions on a drug that has already faced significant reduction of sales since 2007. Supporters of the drug who voted to keep Avandia on the market indicated after the vote that they only did so due to the lack, they said, of hard evidence with regard to potential harm.

They also said Avandia should be used only as a drug of last resort.

That’s good news for rival Actos, manufactured by Takeda Pharmaceuticals. Even though both Avandia and Actos carry black box warnings for fluid retention and the ensuing risk for heart failure, Avandia is thought to carry a greater risk for heart attack than its rival.

So much so, in fact, that the FDA directed the advisory panel to put that matter to a vote, pitting one drug against a rival in an almost unprecedented move. That vote, according to the WSJ, “overwhelmingly” favored Actos as having, in the expert panel’s view, a far lower risk for actual heart attack than Avandia.

David Nathan, director of the diabetes center at Massachusetts General Hospital in Boston, told the WSJ that, “few doctors I know prescribe Avandia on new patients, and many have switched to Actos.” While he found the data on Avandia “worrisome,” he added, “The panel wasn’t willing to pull the trigger. I think the FDA will put heavy restrictions on Avandia.”

There is much speculation on what those restrictions might be. While the FDA now must weigh the results of the expert panel discussions—which occurred July 13^th and 14^th—together with how the panel voted on a number of issues, all eyes are equally focused on Avandia manufacturer Glaxo. Further restrictions mandated by the FDA would serve to tighten the noose around the neck of a drug that has already seen significant loss of sales and has spurred a seemingly endless supply of lawsuits that Glaxo is deeply engaged in settling.

And along with voting to allow Avandia to stay, the panel also voted in favor of allowing the TIDE study, comparing the cardiovascular risks of Avandia with Actos, to continue. It has been reported previously that the TIDE study was having some difficulty recruiting study participants, a finding confirmed to the expert panel by TIDE’s lead researcher, Hertzel Gerstein of McMaster University. Such delays appear to suggest study results will not be available for another five years, at least until 2015.

The various votes by the expert panel are non-binding—although the results do afford the FDA some direction. The focus is now on the FDA to see in which direction the agency attempts to steer Avandia. The head of the agency’s drug division, Janet Woodcock, indicated the FDA would make its decision soon.

That decision, after weighing all the pros and cons, could involve asking Glaxo to remove Avandia from the market. Failing that, the FDA could mandate additional restrictions, something those on the expert panel voting to keep Avandia on the market seemed to require as a stipulation for their ‘yes’ vote.

But what of Glaxo? In order to follow through on the TIDE trial and wait for the results, Avandia would have to remain on the market for at least another five years. In the meantime, the potential for further restrictions by the FDA would likely put further downward pressure on sales. Avandia, according to the WSJ, has gone from selling $2.5 billion globally to about $1 billion now.

Rival Actos, which appears to have benefitted the most from the Avandia saga, reportedly sold $4 billion last year.

While it isn’t a quite a precedent that the FDA actually asked its expert panel to weigh in on whether or not Avandia should stay or go, it comes pretty close to a first, said WSJ writer Alicia Mundy on The News Hub, a video feed posting online July 14^th. Appearing from Washington, Mundy noted that Glaxo itself now must weigh all the pros and cons, not to mention trying to get a read on what the FDA is going to do.

Avandia with new restrictions would be almost certain to suffer increased sales negativity. There is also, according to Mundy, the subject of lawsuits. In the midst of dealing with a sizeable crop of plaintiffs currently, the manufacturer would likely wish to avoid attracting additional litigation. The longer Avandia remains on the market, the more likely those lawsuits will keep coming.

The Wall Street Journal’s Mundy suggested that if Glaxo reads that the FDA may, either now or sometime in the future, be leaning towards asking Glaxo to withdraw Avandia—the manufacturer may simply decide to step in voluntarily, pull the drug “and save themselves the hassle.”

Stay tuned…

Tags: Actos, Avandia, FDA, TIDE

This was posted on Thursday, July 15th, 2010 at 9:32 am and is filed under Drugs/Medical, Emerging Issues . Feel free to respond, or trackback. Read our comments policy.