FDA denies approval for Novartis vaccine

CAMBRIDGE, Mass. The Food and Drug Administration has rejected an approval application for a vaccine by Novartis, requesting additional clinical and manufacturing data.

Novartis announced that the FDA had given it a complete response letter for the investigational vaccine Menveo, asking the Swiss drug maker for additional information on the clinical and Chemistry Manufacturing and Control sections of the application. Novartis submitted the application last August, seeking approval for Menveo as a protection against meningococcus in people ages 11 to 55.

The company said clinical trials had shown Menveo to cause a protective immune response in test subjects against the A, C, W-135 and Y strains of Neisseria meningitides bacteria, which causes potentially fatal meningococcal disease.

“Meningococcal disease is a devastating illness that can result in rapid death, or have long-lasting repercussions for survivors and their families,” Novartis Vaccines and Diagnostics CEO Andrin Oswald said. “We are dedicated to applying our industry-leading technology and expertise to further the development of Menveo and other vaccines that elicit robust, long-lasting, protective immune responses for all age groups at risk.”