Please login to the form below

Not currently logged in
Email:
Password:

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Wyeth Pharmaceuticals has withdrawn a marketing application for Pristiqs from the European Medicines Agency, it announced on March 12

Wyeth Pharmaceuticals has withdrawn a marketing application for Pristiqs from the European Medicines Agency (EMEA), it announced on March 12.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

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Havas Life Medicom

We’re a specialist-led, unified communications agency delivering connected healthcare communications, informed through fresh insights, smart thinking and inspired ideas. Our...

Latest intelligence

Why patient education isn’t simple
Patient education is often understood to be the imparting of knowledge from the healthcare professional (HCP) to the patient and/or their caregiver. However, in most cases, the imparting of knowledge...
Beyond the event
...
Anthill Agency and Actando partnership to Transform Pharma's Digital Skills
Anthill Agency, a leading life sciences digital agency, today announced the launch of the Anthill Academy™ and partnership with Actando's PharmAcademy....

Infographics