Idea AG Withdraws Its Marketing Authorisation Application For Diractin(ketoprofen), Europe

The European Medicines Agency (EMEA) has been formally notified by Idea
AG of its decision to withdraw its application for a centralized
marketing authorisation for the medicine Diractin (ketoprofen) 22.9 mg
gel. Diractin was expected to be used for the symptomatic treatment of
inflammation and pain in osteoarthritis.


The application for the marketing authorisation for Diractin was
submitted to the EMEA on 23 May 2007. At the time of the withdrawal, it
was under review by the Agency's Committee for Medicinal
Products for Human Use (CHMP).


In its official letter, the company stated that the withdrawal of the
application was based on the grounds that the efficacy of the medicine
at the proposed dose has not been sufficiently demonstrated and that
this concern has been identified as a major clinical issue.


More information about Diractin and the state of the scientific
assessment at the time of withdrawal will be made available in a
question-and-answer document. This document, together with the
withdrawal letter from the company, will be published on the EMEA
website in due course.


Notes


1. Withdrawal of an application does not prejudice the possibility
of a company making a new application at a later stage.


European Medicines Agency


View drug information on Ketoprofen.