Pfizer has decided not to push for approval of its investigational osteoporosis drug Brilence in Europe.
The European Medicines Agency says it has been formally notified by Pfizer unit Wyeth of its decision to withdraw its duplicate application for a centralised marketing authori
sation for Brilence (bazedoxifene). The drug was intended to be used for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
Pfizer told the EMA that the reason for the withdrawal of the application was that no co-marketing partner had been identified before
getting an opinion from the agency’s Committee for Medicinal Products for Human Use. The latter issued a positive opinion to Wyeth for bazedoxifene, which was then known as Conbriza, in February 2009 but it would seem that the drug is not seen as a core product for the expanded drugmaker.
More information about Brilence and the state of the scientific assessment at the time of withdrawal will be made available on the EMA’s website after the next CHMP meeting on June 21-24.
