Janssen-Cilag International N.V. Withdraws Its Application For An Extension Of Indication For Invega (paliperidone)

The European Medicines Agency (EMEA) has been formally notified by
Janssen-Cilag International N.V. of its decision to withdraw its
application for an extension of indication for the centrally authorized
medicine Invega (paliperidone) prolonged-release tablets.


Invega was expected to be used for the treatment of acute manic episodes
associated with bipolar I disorder.


Invega was first authorised in the European Union on 25 June 2007. It is
currently indicated for the treatment of schizophrenia.


The application for the extension of indication for Invega was submitted
to the EMEA on 10 September 2008.


In its official letter, the company stated that the withdrawal was based
on the feedback from the early evaluation indicating that the data
provided were not sufficient to support approval for this indication and
the company's view that it was not in a position to adequately address
this issue at that time.


Invega continues to be authorised for the currently approved indication.


More information about Invega and the state of the scientific assessment
at the time of the 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.


2. More information about Invega is available in the European
Public Assessment Report (EPAR):
see here.


3. This press release, together with other information on the work
of the EMEA, can be found on the EMEA website: emea.europa.eu.

European Medicines Agency


View drug information on Invega.