Prevnar gets positive opinion from CHMP

USA-based drug major Wyeth says that its drug Prevenar (pneumococcal saccharide conjugated vaccine, adsorbed) is the subject of two positive opinions from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP). Specifically, the firm said that the CHMP has recommended that the product is approved for the active immunization against pneumonia and acute otitis media.

Currently, the agent is cleared for use in children between two months and five years of age as a preventative measure against sepsis, meningitis, bacteremic pneumonia and bacteremia caused by Streptococcus pneumonia serotypes 4, 6B, 9V, 14, 18C, 19F and 23F.

The Madison, New Jersey-headquartered firm explained that the CHMP's recommendation is based on data from clinical trials which showed that the drug was 97.4% effective against serotype-specific pneumococcal pneumonia, and that it reduced the occurrence of serotype specific AOM 57%. The company went on to say that the drug was also 89.1% effective as a treatment for all cases of pneumococcal pneumonia, regardless of serotype.