The European Medicines Agency has been formally notified by Astellas Pharma
Europe B.V. of its decision to withdraw its application for an extension of the
therapeutic indication for the centrally authorised medicine Qutenza
(capsaicin), 179 mg cutaneous patch.
On 6 May 2011, Astellas Pharma Europe B.V. submitted an application to
extend the marketing authorisation for Qutenza to all adult patients with
exclusion of patients with pain caused by diabetes. At the time of the
withdrawal, the application was under review by the Agency’s Committee for
Medicinal Products for Human Use (CHMP).
Qutenza was first authorised in the European Union on 5 May 2009 and it is
currently indicated for the treatment of peripheral neuropathic pain in
non-diabetic adults either alone or in combination with other medicinal
products for pain.
In its official letter, the company stated that it decided to withdraw the
application based on the CHMP's view that the data provided do not allow the
Committee to conclude on a positive benefit-risk balance.
Qutenza continues to be authorised in the currently approved indication.
More information about Qutenza 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 Agency's website after the 16-19 April 2012 CHMP
meeting.