Experimental Drug Pristiq Approval As Depression Treatment Not To Be Delayed

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FDA's request for more data on Wyeth's experimental drug Pristiq as a nonhormonal treatment for hot flashes and other menopausal symptoms should not delay its approval as a depression treatment, company officials said Tuesday, the AP/Business Week reports (Johnson, AP/Business Week, 7/31).

Pristiqis a new version of Wyeth's depression treatment Effexor, which will lose patent protection in 2010. Wyeth is seeking approval from FDA to market Pristiq as a depression treatment for older women, as well as a treatment for menopausal symptoms. FDA last week issued an approvable letter for Pristiq as a menopausal-symptom treatment, which means that the agency could approve the drug but also usually means the agency needs more information before granting final approval.

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Accordingto Wyeth, FDA in its letter said that before the application could be approved, Wyeth must provide additional data on the potential for serious adverse cardiovascular and hepatic effects associated with the use of Pristiq. In addition, FDA said that Wyeth must address certain chemistry, manufacturing and control deficiencies prior to approval. FDA also made additional clinical and chemistry requests, which it said were not approvability issues (Kaiser Daily Women's Health Policy Report, 7/24).

Wyethofficials said they will work with FDA to speed the drug's approval asa nonhormonal treatment for menopausal symptoms. Greg Norden, Wyeth's CFO, said FDA officials have reassured the company that the additional safety data required for approval as a menopausal symptom treatment will not delay approval of the drug as a depression treatment. "We continue to believe [Pristiq] will receive approval in the first quarter of 2008" for depression, Norden said (AP/Business Week, 7/31).

Reprinted with permission from kaisernetwork.org.You can view the entire Kaiser Daily Women's Health Policy Report, search the archives, and sign up for email delivery at kaisernetwork.org/email. The Kaiser Daily Women's Health Policy Report is published for kaisernetwork.org,a free service of The Henry J. Kaiser Family Foundation. 2007Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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