Astellas Withdraws Application for Extension of Qutenza Indication
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.
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.
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.
The company submitted an application in May 2011 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
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