Novartis AG (NVS) said Friday that a panel of European health regulators recommended approval of its Bexsero vaccine to help prevent devastating Meningitis B infections, the leading cause of meningitis in Europe.
If approved, Bexsero would be the first vaccine in Europe to fight meningitis B and would be a boost to Novartis that has lagged behind rivals in developing vaccines.
The panel, Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), favored the use of Bexsero in individuals from 2 months of age and older.
MenB is caused by bacteria, leading to inflammation of the lining around the brain and spinal cord. It can kill within 24 hours and infants are at highest risk.
Around 10 percent of those who contract the disease die, despite appropriate treatment, and up to one in five survivors suffers from devastating, life-long disabilities such as brain damage, hearing impairment or limb loss.
The European Commission generally follows the recommendations of the CHMP and delivers its final decision within three months. Novartis said it is committed to making Bexsero available as soon as possible and is engaging with governments interested in the early adoption of the vaccine.
The tolerability profile and immunogenicity of Bexsero has been established through a comprehensive clinical program including data from large clinical trials involving almost 8,000 infants, children, adolescents and adults.
In the U.S., Novartis is working with authorities to design Phase III clinical trials.
Novartis stock is trading at $58.78, down 0.32%, on a volume of 1.06 million shares on the NYSE.
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