21. March 2012 13:20
Astellas Pharma Europe B.V. has formally withdrawn its application to extend the indication of Qutenza (capsaicin).
An application was submitted in May 2011 to extend the marketing authorisation for the pain relief patch to all adult patients, with the exception of patients with pain resulting from diabetes.
However, Astellas formally notified the EMA of its withdrawal after the CHMP decided that the data supplied did not allow it to conclude a positive benefit-risk balance for the medication.
Qutenza was first authorised for use in the European Union in May 2009. It is currently indicated for treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medication.