GlaxoSmithKline (NYSE: GSK) is trying again for approval of its meningitis vaccine candidate MenHibrix, which the U.S. Food and Drug Administration has twice declined for approval.
The British drug maker today submitted additional information to regulators supporting its biologics license application for the combination vaccine. GSK, which has its U.S. headquarters is in Research Triangle Park, is trying to bring to market a vaccine that would immunize infants and toddlers to prevent certain forms of meningitis.
MenHibrix combines GSK’s meningococcal and Hib vaccines. Hib is a severe and potentially fatal bacterial infection that can cause meningitits. The information GSK filed with the FDA today is a response to an FDA complete response letter the company received in September declining approval of MenHibrix. GSK had also previously received a complete response letter in 2010 seeking additional information.
GSK did not disclose what concerns regulators had about MenHibrix. In a short statement, GSK said it “will continue to work closely with FDA as the agency continues its review.”
According to the Centers for Disease Control and Prevention, an estimated 1,000 to 3,000 cases of meningococcal disease are reported annually in the United States, typically presenting as meningitis. Approximately 300 of those cases are in infants and toddlers younger than 2, an age group that has the highest rates of meningococcal disease. The disease can be deadly. Those who survive can suffer long term effects of hearing loss, brain damage, amputations and skin scarring.
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