GSK's Synflorix™ receives CHMP positive opinion for major label extension
GSK today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the expansion of the SynflorixTM European label. The updated label now includes effectiveness data for protection against invasive pneumococcal disease (IPD) and pneumonia and acute otitis media (AOM) caused by the pneumococcus bacterium. The effectiveness of the vaccine is due to an impact on pneumococcal disease caused by serotypes included in the vaccine in addition to an impact on serotype* 19A, in children aged 6 weeks up to 5 years of age, as confirmed by the EMA.
Thomas Breuer, Chief Medical Officer at GSK Biologicals said: "GSK welcomes this news. Importantly, the label update affirms what has been observed in real-life settings, and provides clear information about the value Synflorix can provide in helping to protect children against IPD, pneumonia and AOM."
This positive opinion was based largely on two post-marketing studies carried out in Finland and Brazil. The data show a decrease in invasive disease caused by serotypes contained in the vaccine, as well as serotype 19A, following the introduction of Synflorix into the national immunisation programmes (NIPs) in these countries.[i],[ii] Introduction of Synflorix into the Brazilian and Finnish NIPs also notably resulted in an overall decrease in pneumococcal disease in these countries.
Synflorix is indicated for active immunisation against IPD, such as meningitis and sepsis, in infants and children from 6 weeks up to 5 years of age.[iii] In a number of countries, Synflorix has additional indications, including community-acquired pneumonia (CAP), acute otitis media (AOM) caused by Streptococcus pneumoniae (S. pneumoniae), and AOM caused by non-typable Haemophilus influenzae (NTHi).[iv]
Synflorix is licensed in more than 125 countries, and is the vaccine of choice for more than 45 national or regional immunisation programmes.[v]
More than 250 million doses of Synflorix have been distributed worldwide since 2009,[vi] helping to protect more than 70 million children.[vii] GSK was one of the first companies to sign an agreement with Gavi, the Vaccine Alliance, and since 2009, has delivered more than 145 million doses of Synflorix to developing countries.[viii] As part of this ongoing commitment, GSK has agreed to make 720 million doses of Synflorix available by 2025 to help protect children worldwide.[ix]
About pneumococcal disease
Pneumococcal disease refers to infections caused by the bacterium Streptococcus pneumoniae, which can result in severe, and sometimes fatal, invasive disease, such as meningitis, sepsis and bacteraemic pneumonia. More common non-invasive manifestations of pneumococcal disease include sinusitis and AOM, an inflammatory infection of the middle ear, which affects millions of children worldwide.
An estimated 476,000 children under 5 years of age die from pneumococcal disease each year; this accounts for approximately 5% of all-cause mortality in children in this age group.[x]
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Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2014.
*Serotypes refer to distinct variations of S. pneumoniae, of which there are more than 90 different types. Only a small number of serotypes are associated with serious disease, and pneumococcal vaccines are designed to cover the most frequently occurring disease-causing serotypes.