The Food and Drug Administration has sent a complete response letter to GSK regarding the application for the company’s meningococcal and Hib combination vaccine candidate MenHibrix. London-based GSK, which has its U.S. headquarters in Research Triangle Park, North Carolina, has been trying to get approval for MenHibrix to immunize infants and toddlers to prevent certain forms of meningitis.
A complete response letter means the FDA won’t approve a drug candidate without additional information. The letter disclosed today is the second in a little more than a year for MenHibrix. The FDA sent a complete response letter in June 2010 asking for more information. The FDA’s concerns about MenHibrix were not disclosed.
“GSK will work to respond to the questions posed by the FDA,” the company said in a brief statement issued following the close of the financial markets. “The company remains committed to making this vaccine available in the United States.”
The Centers for Disease Control and Prevention estimates that 1,000 to 3,000 cases of meningococcal disease, most commonly presenting as meningitis, are reported annually in the United States. Of those, approximately 300 cases are reported annually in infants and toddlers younger than 2.
One in 10 cases of meningococcal disease results in death. One in five who survive suffer long term effects such as hearing loss, brain damage, amputations and skin scarring. While the disease poses a risk to children, teens and young adults, infants and toddlers under 2 have the highest rates of meningococcal disease. MenHibrix was designed specifically to protect infants and toddlers.