GSK grabs FDA nod for combo meningitis vax

U.S. regulators have stamped an approval on GlaxoSmithKline's ($GSK) combination meningitis vaccine, which is supposed to provide wide coverage against the life-threatening disease for young infants. The FDA's approval of the product, called Menhibrix, could give the London-based drugmaker an edge in the market for meningitis vaccines.

Menhibrix combines vaccines to prevent disease from meningococcal groups C and Y as well as Haemophilus influenzae type b, or Hib. U.S. regulators have licensed the vaccine to be given to infants and children as young as 6 weeks old to 18 months of age, according to the FDA. Glaxo says that most cases of meningitis occur in kids younger than two years old, and infants are the most vulnerable to the potentially deadly disease, which attacks the lining of the brain and spinal cord.

Vaccines for Hib, which was the most common cause of meningitis until vaccines became available in the late-1980s, can already be given in the U.S. to two-month-old infants, Dr. Leonard Friedland, vice president of clinical and medical affairs in North America for GSK, told FierceBiotech. Yet before Menhibrix there were no FDA-approved vaccines against meningococcal groups C and Y that could be given to patients as young as 6 weeks old.

"The disease incidence from meningococcal disease is highest under a year of age, particularly under six months of age, so the opportunity to prevent meningococcal disease caused by serogroups C and Y in young infants is an advance for patients and providers," Friedland said in a phone interview.

An existing vaccine against C and Y serogroups could be given to babies as young as 9 months old, Friedland added. There are no available vaccines against serogroup B. The most common causes of meningitis in the U.S. are serogroups C, Y and B, according to GSK.

Glaxo hasn't yet set a price for Menhibrix, and the company is awaiting a recommendation from the U.S. Centers for Disease Control and Prevention in October on where the vaccine will fit in the agency's schedule of vaccines, Friedland said.

- here's the FDA's release
- see GSK's announcement
- and Reuters' report