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Wyeth withdraws Pristiqs application

Wyeth Pharmaceuticals has withdrawn a marketing application for Pristiqs from the European Medicines Agency, it announced on March 12

Wyeth Pharmaceuticals has withdrawn a marketing application for Pristiqs from the European Medicines Agency (EMEA), it announced on March 12.

The EMEA's Committee for Medicinal Products for Human Use (CHMP) raised questions about the risk-benefit profile of Pristiqs (desvenlafaxine) as a treatment for menopausal vasomotor symptoms (hot flashes).

The company now intends to carry out further studies and continue the development of the drug as a potential treatment.

Dr Gary Stiles, executive vice president and chief medical officer of Wyeth Pharmaceuticals, said: "We believe that desvenlafaxine can provide women with a non-hormonal option to treat vasomotor symptoms, and Wyeth remains committed to developing the molecule for this indication."

"Some of the questions raised by the CHMP can be addressed with our planned clinical trails, including the 12 month study Wyeth is initiating with post-menopausal women early this year," he added.

The original European marketing authorisation was submitted on 4 October 2006 and Pristiqs was under CHMP review at the time Wyeth withdrew the application.

Details and scientific data about the trails will be made published in a question-and-answer document together with the withdrawal letter by the EMEA in due course.

12th March 2008

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