Novartis (NVS) recently received positive news when it obtained U.S. Food and Drug Administration (:FDA) approval for label expansion of its vaccine, Menveo.
The FDA approved the use of Menveo for the protection against meningococcal disease in infants and toddlers aged 2 months and above.
The approval was based on encouraging data from three randomized multicenter studies conducted across the globe among more than 8,700 infants.
Novartis observed that Menveo generated a robust protective immune response among the patients. Moreover, it was generally well tolerated when used with other routine pediatric vaccines.
The approval comes as a relief for Novartis as the FDA had issued a complete response letter (CRL) to the former in 2012 seeking additional data with regard to its supplemental Biologics License Application to expand Menveo’s indication for infants and as well as for toddlers. With the label expansion, Menveo can now be used in infants, children and adolescents.
As per Novartis, meningococcal disease causes approximately 50,000 deaths on an annual basis due to infection from five serogroups—A, B, C, W-135 and Y.
In 2012, Novartis’ Vaccines and Diagnostics Division generated net sales of $1.9 billion, down 7% year over year.
Influenza vaccines are the core products of this division, which include brands such as Fluvirin, Fluad, Agrippal, Begrivac, Optaflu and Flucelvax.
We believe the label expansion of Menveo and approval of Bexsero in early 2013 strengthen Novartis' meningococcal franchise and should boost results going forward.
While Johnson & Johnson carries a Zacks Rank #1 (Strong Buy), Shire and Jazz Pharma carry a Zacks Rank #2 (Buy).
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