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news.San Francisco-based NeurogesX, a biopharmaceutical company focused on pain management therapies, has announced that the European Commission has granted marketing authorization of Qutenza 179 mg cutaneous patch for the treatment of peripheral neuropathic pain in non-diabetic adults.
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Last October, the company submitted a new drug application to the US Food and Drug Administration (FDA) requesting marketing approval of Qutenza. In December 2008, it was accepted by the FDA for review, resulting in a Prescription Drug User Fee Act (PDUFA) date of August 16, 2009. The centralized marketing authorization allows Qutenza to be marketed in all 27 countries of the European Union.
The approval of Qutenza follows a positive opinion recommending approval from the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) on March 19, 2009. NeurogesX anticipates that Qutenza will be marketed in the European Union through a commercial partner.
Anthony DiTonno, President and CEO, said, The European approval of Qutenza represents a major milestone for NeurogesX. Although we expect to commercialize Qutenza in the EU with a commercial partner, we have been preparing for this day for quite some time. We anticipate completing our discussions with a European commercial partner in the next few months and believe that a launch of Qutenza in the EU could take place early next year.