Trade Resources Industry Views Bexsero Won a Positive Opinion From European Medicines Agency's Committee for CHMP

Bexsero Won a Positive Opinion From European Medicines Agency's Committee for CHMP

Bexsero, Novartis' Meningococcal Group B Vaccine, has won a positive opinion from European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).

The CHMP opinion indicates the use of the broad coverage vaccine in individuals older than two months.

Novartis vaccines and diagnostics division head Andrin Oswald said Bexsero represents a major advance within the field of vaccine development.

"For over two decades, our researchers and clinicians have been dedicated to finding a solution to prevent MenB disease," Oswald added.

A clinical program that included Phase II/III clinical trials conducted in 8,000 infants, children, adolescents and adults, demonstrated the tolerability profile and immunogenicity of Bexsero.

According to the company, Bexsero's immunization schedule options can fit with regular vaccination visits.

 

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/novartis-bexsero-wins-positive-chmp-opinion-from-ema-191112
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Novartis Bexsero Receives Positive Opinion From EMA Committee