Qutenza capsaicin regulatory update

EMA said Astellas Pharma Inc. (Tokyo:4503, Tokyo, Japan) withdrew an application for a label extension for Qutenza capsaicin patch to treat peripheral neuropathic pain in adults, except when pain is caused by diabetes. According to the agency, Astellas said EMA's CHMP indicated the data provided was not sufficient to demonstrate a positive benefit-risk balance. The dermal patch containing capsaicin is approved in the EU to treat peripheral neuropathic pain in non-diabetic adults. Astellas has rights to commercialize Qutenza from NeurogesX in more than 30 European countries, as well as the Middle East and Africa (see BioCentury, June 29, 2009). ...