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.
The British drug maker today submitted additional information to regulators that supports its biologics license application for the combination vaccine. GSK, which has its U.S. headquarters is in Research Triangle Park, North Carolina, 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 meningitis. The information GSK filed with the FDA today is a response to an FDA complete response letter the company received in September that declined 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.
Reserve your seat now for MedCity CONVERGE, to be held July 9-10 in Philadelphia. Discover strategies, solutions and startups in healthcare innovation. Be a part of this gathering where the entire healthcare ecosystem converges.
By Frank Vinluan
Frank Vinluan is the North Carolina Bureau Chief for MedCity News.More posts by Author
- Get Livefyre
- FAQ
