EMA CHMP Gives Positive Opinion to Glaxo's (GSK) Nimenrix
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GlaxoSmithKline (NYSE: GSK) reports that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for Nimenrix (MenACWY-TT) for active immunisation against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y.
A CHMP positive opinion is one of the final steps before regulatory approval. As part of its assessment, CHMP reviewed immunogenicity and safety data from more than 8000 patients aged 1 year and above. The clinical program included 17 clinical studies conducted in 17 countries worldwide.
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A CHMP positive opinion is one of the final steps before regulatory approval. As part of its assessment, CHMP reviewed immunogenicity and safety data from more than 8000 patients aged 1 year and above. The clinical program included 17 clinical studies conducted in 17 countries worldwide.
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