Navidea submits Lymphoseek application to EMABy AuntMinnieEurope.com staff writers
December 19, 2012 -- Radiopharmaceutical developer Navidea Biopharmaceuticals has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for its investigational radiopharmaceutical Lymphoseek injection, an intraoperative lymphatic mapping agent.
The application proposes the use of Lymphoseek (technetium-99m tilmanocept) in general lymphatic mapping, not restricted to any particular solid tumor type. It is supported by a clinical program that includes results from two phase III studies performed in patients with either breast cancer or melanoma, according to Navidea.
Navidea is also seeking marketing approval of Lymphoseek in the U.S., the company said.
Navidea seeks to market Lymphoseek in Europe, February 3, 2012
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Last Updated np 12/18/2012 4:55:02 PM