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Novartis' Meningococcal Group B Vaccine Bexsero Gets EU Approval - Update

1/22/2013 3:31 AM ET

Swiss drugmaker Novartis AG (NVS: Quote) on Tuesday announced that the European Commission has approved Meningococcal Group B or MenB Vaccine Bexsero for use in individuals from 2 months of age and older.

Bexsero is the first vaccine to prevent the leading cause of life-threatening meningitis across Europe. The drug is indicated to help protect all age groups against MenB disease, including infants who are the most vulnerable. Novartis said it is working with health authorities to provide access to Bexsero as soon as possible.

According to the company, MenB disease, a bacterial infection, is the leading cause of meningitis across Europe, particularly in infants. The disease is rare, but affects healthy people without warning, and could turn fatal or leave patients with severe disabilities. Its symptoms can be easily misdiagnosed in its early stages as it often resemble the flu. Prevention through vaccination is therefore the best defense against this aggressive disease, the company added.

Bexsero, the result of Novartis' pioneering vaccine research, offers several immunization schedule options that could fit with routine vaccination visits, starting at two months of age.

Meningitis UK Founder Steve Dayman MBE said, "This meningitis B vaccine is the most important medical breakthrough in the 30 years since I lost my son to the disease. It could save thousands of lives and prevent other parents suffering the same tragedy. The vaccine must be made widely available through the immunisation schedule as soon as possible - any delay could mean lives lost."

Following today's approval, EU member states will evaluate Bexsero for potential inclusion into national immunization programs and, where relevant, reimbursement schemes.

Novartis said it is already engaging with governments interested in the early adoption of the vaccine.

Novartis, with its Bexsero and Menveo drugs, helps to protect against all five main serogroups of meningococcal bacteria that cause the majority of cases around the world.

In Zurich, Novartis shares are currently trading at 60.80 Swiss francs, down 0.10 francs or 0.16 percent.

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by RTT Staff Writer

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