European Commission and US Food and Drug Administration grant a marketing authorization for Menveo®

Published March 24th, 2010 - 01:18 GMT

Novartis announced today that the European Commission (EC) granted a Marketing Authorization for Menveo® (Meningococcal Group A, C, W135 and Y conjugate vaccine) in all 27 European member states. Menveo was also approved by the US Food and Drug Administration (FDA) on the 21st of February 2010

Menveo is indicated for the active immunization of adolescents (from 11 years of age) and adults at risk of exposure to Neisseria meningitidis groups A, C, W135 and Y, to prevent invasive disease.

Menveo is the first conjugate vaccine commercially available in Europe that helps protect against four major groups of meningococcal disease. Novartis intends to submit additional data to the European Medicines Agency to support the use of Menveo in other age groups.

Meningococcal disease infects more than 500,000 people each year, leading to more than 50,000 deaths globally2. As many as 1 in 7 patients who contract meningococcal disease die from it3. Approximately 1 in 5 meningococcal disease survivors suffer serious, permanent and devastating side effects, including limb amputations, seizures, paralysis, hearing loss and learning disabilities. “Even with early and appropriate treatment, patients can die from meningococcal disease, often within 24-48 hours of onset of symptoms.

This Vaccine is of high importance during the Hajj and Umrah pilgrimage. Approximately 2.5 million Muslims perform Hajj and in addition 3-4 million participate in Umrah every year. Due to the high visitor density, crowded conditions and the low humidity of the dry season an increase in the risk of infection may occur.

There have been multiple meningococcal outbreaks in the years 1987, 1999-2001 within Saudi Arabia. Up to 20% of visitors return to their home countries carrying Meningococcal bacteria.
Now Saudi Arabia is recommending every pilgrim going to Hajj and /or Umrah to get vaccinated against bacteria of Serogroups ACWY.

Menveo was developed using conjugate technology, which was pioneered by Novartis Vaccines
“Menveo achieved a higher immune response than the other currently available vaccine, which is very reassuring,” said Keith S. Reisinger, MD, Medical Director, Primary Physicians Research, Inc., Pittsburgh, Penn.

Approval of Menveo is the result of 10 years of dedicated effort by Novartis Vaccines to provide a vaccine that can help protect people against meningococcal disease.

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