Date: 2012-02-16
Type of information:
Product name: Menveo®
Compound: Meningococcal [Groups A, C, Y and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
Therapeutic area:
Action mechanism: vaccine
Company: Novartis (Switzerland)
Disease: prevention of meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y
Latest news: * On August 1, 2013, Novartis has announced that the FDA approved Menveo® (Meningococcal Group A, C, W-135 and Y conjugate vaccine) for the prevention of meningococcal disease caused by four strains of Neisseria meningitidis in infants and toddlers from 2 months of age. With this expanded indication, pediatricians in the US can now offer a single vaccine for the protection of infants, children and adolescents against four of the five most common serogroups that cause meningococcal disease. This FDA approval was based on data from three randomized multicenter studies involving more than 8,700 infants, conducted in Australia, Canada, Latin America, Taiwan and the US. The studies demonstrated that Menveo® generated a robust protective immune response and was generally well tolerated when administered with other routine pediatric vaccines.Menveo® has been available for use in adolescents and adults (11 to 55 years of age) since February 2010 and in children (2 to 10 years of age) since January 2011.
* On February 13, 2012, Novartis announced that it has received a Complete Response letter from the FDA on its application for the expanded use of Menveo® in infants and toddlers from 2 months of age. 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.* On June 16, 2011, Novartis announced that the 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.Novartis has received approval from the FDA for the use of Menveo® (Meningococcal [Groups A, C, Y and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine) for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in individuals 2 to 10 years of age. Menveo® received initial FDA approval in 2010 for use in adolescents and adults from 11 to 55 years of age. The FDA approval of Menveo® for use in children 2 to 10 years of age is based on Phase III trial data involving 5,297 participants in that age group. In the pivotal trial, the safety and immunogenicity of Menveo® against each of the four serogroups were compared with those of the other currently US-licensed ACW-135Y meningococcal conjugate vaccine. Novartis also agreed to conduct three post marketing studies.Separately, Novartis received a Refuse To File (RTF) letter from the FDA regarding the Company's supplemental Biologics License Application (sBLA) for the use of Menveo® in infants from 2 to 12 months. The sBLA had been submitted to the FDA in November 2010. Novartis plans to resubmit a sBLA in 2011 for the expanded use of Menveo® in infants and toddlers from 2 months to 2 years old.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2010-02-19, 2011-01-28, 2013-08-01
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
