FDA approves Menveo

CAMBRIDGE, Mass. Novartis has received Food and Drug Administration approval for a vaccine for meningococcal disease, the Swiss drug maker’s vaccines division announced Monday.

The FDA approved Menveo (meningococcal [groups A, C, Y and W-135] oligosaccharide diphtheria CRM197) to prevent meningococcal disease caused by Neisseria meningitidis bacteria.

The disease infects more than 500,000 people each year, killing as many as 1-in-7 who contract it; it is often fatal within 48 hours. About one-in-five who survive have serious side effects, including limb amputations, learning disabilities, seizures and paralysis.

“The FDA approval of Menveo is an important milestone for adolescent immunization in the United States,” Novartis vaccines division head Andrin Oswald said in a statement. “According to CDC estimates, approximately 16 million adolescents between the ages of 11 and 18 are at risk and remain unprotected against meningococcal disease.”