Novartis application for expanded Menveo® indication from 2 months of age accepted for review by FDA

Novartis announced today that the US Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) to expand the Menveo® (Meningococcal [Groups A, C, Y and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine) indication to include infants and toddlers from 2 months of age. Menveo is already approved in the US for use in individuals 2 years to 55 years of age[3].

The sBLA is supported by data from pivotal trials which included more than 6,000 infants and toddlers worldwide. In the trial measuring the body’s immune response (immunogenicity) to the vaccine one month after completion of a four dose Menveo series administered at 2, 4, 6 and 12-16 months of age, 100% of subjects achieved the correlated protection level (hSBA titers >=8) against serogroups W-135 and Y, and 94% and 98% of subjects achieved this level against serogroups A and C, respectively[1]. Menveo was generally well tolerated when administered either alone or with other pediatric vaccines[4].

The application accepted today includes infant data aged 2 to 12 months as well as additional data that support the use of Menveo in toddlers from 12 to 23 months of age.

The highest rates of meningococcal disease occur early in the first year of life, with most cases occurring within the first 7 months[2],[5]. About one in 16 infants who contract meningococcal disease may die[5]. Survivors may suffer permanent brain damage, learning disabilities, hearing loss and limb loss[6]. In most cases, the resulting side effects require life-long, expensive medical treatment and ongoing assistance[7].

About Menveo

As of June 2011, Menveo is registered in more than 40 countries for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y. Menveo has been administered to more than 21,500 participants in clinical trials across all age groups worldwide, and studies are ongoing in infants, toddlers, adolescents and adults. Menveo received FDA approval in February 2010 for use in adolescents and adults (11 to 55 years of age) and approval for use in children 2 to 10 years of age in January 2011.

In the European Union, Menveo is indicated for use in persons 11 years and above. Novartis plans to submit additional data to the European Medicines Agency to support the use of Menveo in infants and children 0 to 10 years of age in the coming months. An application to support a label extension for use in children 2 to 10 years of age has been submitted in Canada.

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 following administration of Menveo.

Vaccinees 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 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, erthema, irritability, induration, sleepiness, malaise, and headache. Some events were severe. Safety has not been established in pregnant women. Vaccination with Menveo may not protect all individuals. Before administering Menveo, please see full Prescribing Information.

References

1. Novartis Data on File.
2. Centers for Disease Control and Prevention. Vaccines and Preventable Diseases. Factsheet: Meningococcal Diseases and Meningococcal Vaccines. August 2009. Available at: http://www.cdc.gov/vaccines/vpd-vac/mening/vac-mening-fs.htm. Accessed on May 31, 2011.
3. Novartis. Menveo® Full Prescribing Information. January 2011.
4. Klein NP, Gill CJ, Bedell L, Karsten A, Dull PM. Pivotal safety and immunogenicity of an investigational quadrivalent meningococcal vaccine (MenACWY-CRM; Menveo®) in 4545 infants. Presented at the 48th Annual Meeting of the Infectious Diseases Society of America in Vancouver, British Columbia, Canada on October 21-24, 2010.
5. Cohn, A. et al. Changes in Neisseria meningitidis Disease Epidemiology in the United States, 1998-2007: Implications for Prevention of Meningococcal Disease. Clinical Infectious Diseases 2010:50.
6. Centers for Disease Control and Prevention. Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book: Course Textbook). 10th Edition, 2nd printing. April 2011 update. Available at: http://www.cdc.gov/vaccines/pubs/pinkbook/default.htm. Accessed on May 31, 2011.
7. Schaffner, W. et al. The changing epidemiology of meningococcal disease among US children, adolescents, and young Adults. National Foundation for Infectious Diseases. November 2004. Available at: http://www.nfid.org/pdf/meningitis/FINALChanging_Epidemiology_of_Meningococcal_Disease.pdf. Accessed on May 31, 2011.