DiagnosticsGendux Molecular Limited Withdraws Its Marketing Authorisation Application For Contusugene Ladenovec Gendux (contusugene Ladenovec)
The European Medicines Agency has been formally notified by Gendux
Molecular Limited of its decision to withdraw its application for a
centralised marketing authorisation for the medicine Contususgene
ladenovec Gendux (contusugene ladenovec), suspension for injection.
Contusugene ladenovec Gendux was expected to be used for the treatment
of squamous cell carcinoma in head and neck cancer.
The application for the marketing authorisation for Contususgene
ladenovec Gendux was submitted to the Agency on 2 July 2008. At the time
of 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 difficult financial situation of its parent
company Introgen Therapeutics, Inc., which prohibits them to fund
further activities related to this application.
More information about Contusugene ladenovec Gendux 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 Agency"s
website shortly.
European Medicines Agency