US FDA approves Sanofi-Pasteur's Menactra for infants and extends GSK's Lamictal use; Merck/Sanofi combo vaccine moves into Ph III

The US Food and Drug Administration on Friday approved the use of Sanofi-Aventis (Euronext: SAN) vaccine unit Sanofi Pasteur’s Menactra in children as young as nine months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Menactra already is approved for use in people aged two through 55 years.

Although the rates of meningococcal disease are low in the USA, infants and toddlers are more susceptible to getting this serious illness. Meningococcal disease is particularly dangerous because it progresses rapidly and can cause death within hours. Early symptoms are often difficult to distinguish from influenza and other common illnesses.

“The highest rate of meningococcal disease occurs in children under one year of age. With today’s approval, Menactra can now be used in children as young as 9 months of age to help prevent this potentially life-threatening disease,” said Karen Midthun, Director of FDA's Center for Biologics Evaluation and Research.