Wyeth Pharmaceuticals, a division of Wyeth (WYE), said Wednesday that it has decided not to pursue its central European Marketing Authorization Application at this time for desvenlafaxine, or Pristiq, for the treatment of major depressive disorder, or MDD, in adults. Desvenlafaxine represents Wyeth's newest antidepressant therapy.
Wyeth said the decision has been arrived at in consultation with the Committee for Medicinal Products for Human Use of the European Medicines Agency.
Desvenlafaxine has already been approved for the treatment of MDD in adults in the United States, Australia and Brazil. The Madison, New Jersey-based company disclosed that applications are currently pending in 22 markets for desvenlafaxine.
Wyeth said it remains committed to making desvenlafaxine available to patients with MDD around the world, including in Europe.
Earlier, on March 3, Wyeth voluntarily withdrew its application for a centralized European Marketing Authorization for desvenlafaxine 500mg and 100mg prolonged release tablets for the treatment of vasomotor symptoms, or hot flashes, associated with menopause.
The company's decision was on the grounds that additional clinical studies need to be conducted to address questions from the Committee for Medicinal Products for Human Use regarding the risk-benefit profile of desvenlafaxine as a treatment for vasomotor symptoms.
WYE is trading down $0.62 or 1.85% at $32.88 on a volume of 978 thousand shares.
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