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Novartis Gets Positive CHMP Opinion For Bexsero; Exjade Recommended By CHMP

Novartis AG (NVS) announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has adopted a positive opinion for Bexsero (Meningococcal Group B Vaccine [rDNA, component, adsorbed]) for use in individuals from 2 months of age and older.

Upon regulatory approval, Bexsero will be the first licensed broad coverage vaccine that can help protect all age groups against MenB disease, including infants, the age group at the greatest risk of infection.

Dr Matthew Snape, consultant in Pediatrics and Vaccinology at the Oxford Vaccine Group, University of Oxford, stated, "MenB disease is a major cause of meningitis and septicemia in children, and its ability to cause a rapidly progressive, devastating illness makes it one of the infections most feared by both parents and pediatricians. A vaccine that is able to reduce the incidence of this disease would be a major advance towards the prevention of childhood meningitis."

Separately, Novartis announced that the CHMP of EMA adopted a positive opinion for Exjade (deferasirox) for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients aged 10 years and older with non-transfusion-dependent thalassemia syndromes. Exjade would be the first oral treatment in the European Union specifically indicated for the treatment of iron overload in patients with these types of thalassemia.

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