FDA requests additional data on Novartis

Basel, February 13, 2012 - Novartis has received a Complete Response letter from the US Food and Drug Administration (FDA) on its application for the expanded use of Menveo (Meningococcal [Groups A, C, Y and W-135] Oligosaccharide Diphtheria CRM₁₉₇ Conjugate Vaccine) in infants and toddlers from 2 months of age. Menveo is already approved for use in individuals 2 to 55 years of age in the US.

Novartis submitted the supplemental Biologics License Application (sBLA) for Menveo to the FDA in April 2011. The Complete Response letter indicates the FDA has completed the current review cycle and requests answers to additional questions prior to proceeding with further review of the sBLA. Novartis will work with the FDA to address these questions.

About Menveo
As of February 2012, Menveo is registered in more than 50 countries for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y. Menveo received the FDA approval for use in adolescents and adults (11 to 55 years of age) in February 2010 and approval for use in children 2 to 10 years of age in January 2011. Since launch, more than 3 million doses of Menveo have been distributed worldwide. Studies are ongoing in infants, toddlers, adolescents and adults.

Important Safety Information
Menveo is contraindicated in individuals who have experienced a severe allergic reaction after a previous dose of Menveo, any component of this vaccine, or any other CRM₁₉₇, diphtheria toxoid or meningococcal-containing vaccine. Appropriate medical treatment must be available should an acute allergic reaction, including an anaphylactic reaction, occur follow administration of Menveo.

Those vaccinated may develop syncope, sometimes resulting in falling with injury associated with seizure-like movements. Observation for 15 minutes after vaccination is recommended. Patients who are immunocompromised or receiving immunosuppressive therapy may have an inadequate response to vaccination.

Following vaccination with another US-licensed meningococcal quadrivalent polysaccharide conjugate vaccine, an evaluation of postmarketing adverse events suggested a potential for an increased risk of Guillain-Barré syndrome (GBS). Data are not available to evaluate the potential risk of GBS following administration of Menveo.

In clinical trials, the most frequently occurring adverse events in subjects 11 to 55 years of age who received Menveo were pain at the injection site, headache, myalgia, malaise, and nausea. The most frequently occurring adverse events in subjects 2-10 years of age who received Menveo were pain at the injection site, erythema, irritability, induration, sleepiness, malaise, and headache. Safety has not been established in pregnant women. Vaccination with Menveo may not protect all individuals.

Before administering Menveo, please see full Prescribing Information.