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FDA Expands Use Of Sanofi's Meningitis Vaccine October, 2007





The Food and Drug Administration said Thursday it expanded the approved age range for Menactra, a bacterial meningitis vaccine, to include children ages 2 to 10 years.

Menactra, made by a U.S. unit of Sanofi-Aventis SA (SNY), was first approved by the FDA in January 2005 for people ages 11 to 55. Another meningitis vaccine, also by Sanofi, had been the only FDA-approved vaccine for use in children ages 2 and older.

Meningitis is a serious inflammation of the lining that surrounds the spinal cord and brain and can result in death or permanent injury to the brain and nervous system.

The FDA said about 2,600 people become ill from bacterial meningitis in the U.S. each year, and about 10% of those die and another 15% of people suffer brain damage or limb amputation.

The FDA said Guillain-Barre syndrome, a neurological disorder that causes muscle weakness, is a possible but unproven risk associated with the vaccine, although the disorder was not seen in clinical trials. GBS has been reported in some adolescents following immunization with Menactra. The FDA said the rate is estimated at one in 1 million vaccine recipients. As a precaution, people who have previously been diagnosed with GBS should not receive Menactra, the agency said.

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