The FINANCIAL — Novartis AG (NVS: News ) announced that Menveo, a quadrivalent meningococcal conjugate vaccine was approved by the US Food and Drug Administration for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in people 11 to 55 years of age.
According to AP, Menveo is a vaccine against four common types of bacterial meningitis, which affects between 1,000 and 3,000 people each year in the United States.
"The FDA approval of Menveo is an important milestone for adolescent immunization in the United States. According to CDC estimates, approximately 16 million adolescents between the ages of 11 and 18 are at risk and remain unprotected against meningococcal disease," said Andrin Oswald, Division Head of Novartis Vaccines and Diagnostics, Novartis informs. "Meningococcal disease is particularly distressing because it can rapidly kill or debilitate previously healthy adolescents. For this reason, we are dedicated to helping eradicate meningococcal disease in the United States and around the world."
Novartis also pulled further ahead of German rival Merck KGaA in the bid to get the first oral MS treatment to market after its drug Gilenia, FTY720, was granted U.S. priority review status, Reuters reports. Novartis is competing with Merck MGaA's pill cladribine against the debilitating nervous disease and has edged ahead since the German group suffered a setback last year, when U.S. regulators held up its application to bring its cladribine drug to market.
The priority review for Gilenia, which cuts the standard review time to six months from 10, comes after the U.S. Food and Drug Administration accepted the regulatory submission made in December for the drug, according to the same source. "The priority review status is a nice little surprise which may move the launch forward from late 2010," said Thomas Maul, an analyst at DZ Bank, who expected sales of the drug to reach at least $1 billion a year.
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, RTT News reports. The Menveo development program for other age groups continues in multiple Phase III clinical trials.
According to the same source, Novartis plans to seek licensure of Menveo in infants and children 2-10 years of age. Data to support an indication for children 2 to 10 years of age is expected to be submitted in the first half of 2010. Novartis expects to file data to support an infant indication in 2011.