Furious Seasons

May 08, 2009

Leading Psychiatrist Amazed By Fanapt Approval

There's still quite a bit of attention being paid to Wednesday's surprise FDA approval of Vanda Pharmaceuticals' atypical antipsychotic Fanapt for use in schizophrenia. Surprised was Columbia University psychiatrist Jeff Lieberman, who told Forbes.com:

"Lieberman says he is 'amazed' the FDA approved the drug. He says the approval is 'probably a testament to persistence' on Vanda's part. 'There's no harm in having it,' he says. 'It gives clinicians another option to choose from, but it doesn't really add anything in terms of any substantial advance in efficacy or safety.'"

As far as I know none of the approval studies have been published yet, so it's tough to know what the drug's safety and efficacy might be. Like almost everyone who follows these issues, I was stunned that the FDA approved a drug it had issued a not approvable letter for last year, especially in light of the fact that Vanda didn't run new clinical trials but went back to the FDA with essentially the same trials and data it had submitted earlier. So you've got to wonder if they made a scientific argument to the FDA that the agency's reviewers missed something in the data or if the company made a legal argument that the agency had to approve the drug since it had shown basic efficacy.

Forbes.com noted that it might mean the FDA is lowering the bar on approval of new antipsychotics and there are other compounds out there which could potentially gain approval.

It's hard to know since the FDA approval process is ridiculously secretive, but the whole affair has me scratching my head with both hands. As does the drug's name. Where the hell did they come up with Fanapt?

Feel free to speculate in comments.

Posted by Philip Dawdy at May 8, 2009 12:01 AM

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Comments

I remember being stunned when Cymbalta was approved. This was after several failed attempts -- duloxetine had been in and out of approval for years. Then there was the suicide of a healthy volunteer in the clinical trial. None of this made the blindest bit of difference to the final approval (for depression) and furthermore now the drug has gone on to be a blockbuster (and I'm sure a killer of innocent people in one way or another). This is just the normal way of doing business at the FDA and we shouldn't be surprised at all. It's history repeating itself over and over again.

Posted by: Sara at May 7, 2009 11:44 PM

I track just about all upcoming possible new antipsychotics, and this one shocked me as well, and quite frankly, I thought your post last time was a joke due to the name "Fanapt".

I think this is a political, insider move, I mean an 800% increase in stock value for Vanda as a result? the FDA is a tainted agency, not to be trusted as people tend to believe (FDA approved means buyer beware as far as I am concerned).

As with Geodon, the last drug that was full of side effects such as heart issues---this one appears to be the same. (Geodon approval for use in kids? you have to be kidding)

Posted by: Stephany at May 8, 2009 12:51 AM

I checked a bit out on it, and the fact that the prescribing information states: "In choosing among treatments, prescribers should consider the ability of FANAPT to prolong the QT interval and the use of other drugs first." seems rather alarming to me. Sounds like a prescription for sudden death by cardiac arrest.

The name... IMO, they should consider some turnover among the staff of their marketing department. So that things like "Fanapt" won't happen another time...

Posted by: Marian at May 8, 2009 10:36 AM

It occurs to me that Fanapt might rhyme with inept which is more apropos of the FDA than Vanda perhaps but still strikes the right note somehow.

Posted by: Sara at May 9, 2009 02:32 AM

Yes, SteveB I know what "to prolong the QT interval" means. Prolong the QT interval too long, it means you're dead.

Posted by: Lisa at May 9, 2009 02:21 PM