Navidea Biopharmaceuticals, Inc. NAVB, a biopharmaceutical company
focused on precision diagnostic radiopharmaceuticals, today announced that it
has submitted a Marketing Authorization Application (MAA) for its
investigational radiopharmaceutical Lymphoseek^® (technetium Tc 99m
tilmanocept) injection, a novel intraoperative lymphatic mapping (ILM) agent,
to the European Medicines Agency (EMA).
“The submission of the Lymphoseek MAA marks a significant milestone for
Navidea as we continue our global development and commercialization efforts
for Lymphoseek. It is also important to note that, as part of the normal MAA
filing process, the EMA required good manufacturing practices (GMP)
pre-submission inspections at the Lymphoseek contract manufacturing
facilities. These inspections were recently successfully completed by
independent auditors from the European Union (EU), thereby enabling our MAA
filing,” commented Dr. Mark Pykett, President and CEO of Navidea. “We are
encouraged by these positive pre-submission manufacturing audits which we
believe bode well for Lymphoseek's ultimate commercialization. We are prepared
to support the ongoing EMA approval process and to continue our
pre-commercialization activities as we confidently anticipate U.S. approval of
Lymphoseek in the coming months.”
Navidea is seeking marketing approval for Lymphoseek in the EU for use in ILM,
a surgical oncology procedure in which lymph nodes draining the area around a
tumor are identified and biopsied to determine if cancer has spread to the
lymph nodes. The Lymphoseek MAA has proposed the use of the agent in general
lymphatic mapping not restricted to any particular solid tumor type. According
to the European Union's FACT Public Health Programme Fighting Against Cancer,
approximately 2.2 million new cases of solid tumor type cancers are expected
to be diagnosed in the EU.^i
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