Healthcare major GlaxoSmithKline plc's (GSK: Quote,GSK.L) said Thursday it has received the U.S. Food and Drug Administration approval for the Biologics License Application or BLA, for its combination meningitis vaccine MenHibrix for infants to protect against two bacterial diseases.
The combination vaccine is administered as a four-dose series at 2, 4, 6 and 12 through 15 months of age.
The FDA said MenHibrix is the first meningococcal vaccine that can be given starting as early as six weeks of age. Menhibrix is manufactured by Rixensart, Belgium-based GlaxoSmithKline Biologicals.
It is approved for active immunization of infants and toddlers between the ages 6 weeks and 18 months against invasive diseases caused by Neisseria meningitidis serogroups C and Y, and Haemophilus influenzae type b (Hib) infections.
Meningococcal disease is a rare but serious bacterial infection caused by the bacterium N. meningitidis. Meanwhile, Hib disease is caused by the bacterium Haemophilus influenzae type b, which most commonly presents as meningitis. These bacteria can infect the bloodstream causing sepsis, and the lining that surrounds the brain and spinal cord causing meningitis.
This was the third attempt by U.K.-based GlaxoSmithKline to get approval for the vaccine in the U.S. It was asked to submit additional information to the FDA to support its BLA in the earlier attempts. The BLA for MenHibrix had been turned down by the FDA, seeking additional information, first in September 2011 and earlier in June 2010 as well.
The approval was based on safety data for Menhibrix from 7,521 infants and toddlers in the U.S., Mexico, Australia, Belgium and Germany. The company noted that common adverse reactions reported after administration of Menhibrix were pain, swelling and redness at the injection site, irritability, drowsiness, fever, and loss of appetite.
GSK closed Thursday's regular trading session at $45.31, up $0.24 or 0.53% on a volume of 1.59 million shares, lower than the three-month average volume of 2.24 million shares.
GSK.L closed on the London Stock Exchange at 1,459.50 pence, up 4.50 pence or 0.31% on a volume of 10.23 million shares.
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by RTT Staff Writer
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