FDA delays decision on Wyeth menopause drug

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x-no-archive: yes

July 24, 2007, 8:02 am
FDA Delays Decision on Wyeth Menopause Drug
Posted by Jacob Goldstein

The FDA said late yesterday it wasn't ready to approve Pristiq, a drug
derived from Wyeth's antidepressant Effexor XR and intended to treat
hot flashes and other symptoms of menopause, the WSJ reports.

The FDA told Wyeth to do a year-long study of the drug to see whether
it is associated serious cardiovascular or liver problems, the company
said this morning.

In trials, Pristiq has caused nausea and other side effects. And there
have been a few signs that it may raise the risk of cardiovascular
problems.

Before the announcement, analysts had been divided about which way the
FDA would go. Lehman Brothers' Tony Butler wrote in a note this
morning that he had expected approval, given that the current
menopause treatment, hormone replacement therapy, "has its issues."
But, as the Health Blog noted, the company's tone in last week's
earnings call made some analysts skittish. The "guarded commentary,"
Merrill Lynch's David Risinger wrote after the call, "causes us to
have less conviction in a timely approval."

Wyeth's holding a conference call about Pristiq before the market
opens.

Update: WSJ's Sarah Rubenstein reports from this morning's conference
call. Gary Stiles, Wyeth's chief medical officer, said the FDA's
questions related to a small number of patients who experienced
increases in liver enzymes or had cardiovascular problems during
trials. The liver issue wasn't unique to Pristiq, and the company
looked carefully at the cardiovascular issues, he said. Wyeth doesn't
believe the problems were caused by Pristiq.

Stiles said he didn't yet know what size trial the agency wants, but
Wyeth isn't "even contemplating" dropping its pursuit of approval of
the drug for menopause symptoms. He added that he didn't expect FDA's
letter to affect the company's application for use of the drug as an
antidepressant.

In midday trading Wyeth shares were off $4.40, or 7.9%, to $51.60.

Thanks Susan, I was just about to post this. Well as I have the URLS
in front of me....

http://www.nytimes.com/2007/07/24/bu...=1&oref=slogin
>
>F.D.A. Seeks More Information From Wyeth on Menopause Drug

[small quote]
>Some analysts previously expressed skepticism over the drug’s chances for full approval,
>pointing out that Wyeth had been sending the agency additional research on the drug since
>submitting it for review. In an earnings call last week, Wyeth said it was testing a lower-dose
>version of Pristiq aimed at decreasing adverse side effects, including nausea, that could
>limit use of the treatment.

I'll bet.

Or for those not able to get into the NY Times site

http://www.reuters.com/article/marketsNews/idUSN2442193420070724>

>Wyeth's Pristiq hit by FDA heart, liver concerns

Kathryn