FDA approves MenHibrix
PHILADELPHIA — GlaxoSmithKline has received regulatory approval from the Food and Drug Administration for a vaccine designed to prevent invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type B.
MenHibrix (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid conjugate vaccine) is approved for use in children ages six weeks through 18 months. The vaccination schedule is a four-dose series given at two, four, six, and 12 through 15 months of age.
"All of us at GSK vaccines look at today's approval as a good day for infants, toddlers and healthcare providers," said Leonard Friedland, VP and head of clinical and medical affairs of North America vaccine development for GSK Vaccines. "MenHibrix gives healthcare providers the option of combining Hib immunization with meningococcal C and Y immunization without increasing the number of shots for infants and toddlers."
In September 2011, the FDA declined to approve the drug and sent GSK a complete response letter.