EMEA accepts GSK's Synflorix for review

UK-based drug major GlaxoSmithKline says it developmental pediatric pneumococcal vaccine candidate Synflorix (Pneumococcal Haemophilus influenzae protein D conjugate vaccine) has been accepted for review by the European Medicines Agency (EMEA). The product is designed to protect against both invasive pneumococcal disease and bacterial respiratory infections.

In most cases, invasive pneumococcal diseases such as meningitis, invasive pneumonia and bacteremia, are a result of infection by strains of the organism Streptococcus pneumoniae. Synflorix is formulated to induce an immunological response to the 10 most common disease causing S pneumoniae serotypes, which are responsible for 80% of IPD cases worldwide. The drug also includes the highly-immunogenic D protein derived from non-typeable H influenzae in order to provide a broader range of protection.

GSK added that Synflorix is also being developed for the treatment of the inner ear disorder otitis media, which is often associated with upper respiratory tract infections in children. The firm added that the condition is one of the most common pediatric illnesses worldwide, and is the indication for which most antibiotics are prescribed.