Astellas pulls EU application to extend use of Qutenza
The European Medicines Agency has been formally notified by Astellas Pharma Europe, a subsidiary of Japanese drug major Astellas (TYO: 4503) of its decision to withdraw its application for an extension of the therapeutic indication for the centrally authorized neuropathic pain drug Qutenza (capsaicin), 179mg cutaneous patch.
On May 6, 2011, Astellas 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 authorized in the European Union in 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.
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