Pfizer receives new regulatory approval for Prevnar 13
3 January 2012 00:00 in Pharmaceutical Company Product News
Pfizer has received a positive regulatory decision from the US Food and Drug Administration (FDA) on its pneumococcal conjugate vaccine Prevnar 13.
The treatment has been ratified as a single-dose treatment for adults aged over 50 against pneumonia and invasive disease caused by 13 common Streptococcus pneumoniae serotypes, as well as for use in active immunisation programmes.
Prevnar 13 has demonstrated its safety and efficacy in phase III studies conducted among more than 6,000 patients, during which it was shown to deliver a strong functional antibody response.
Currently, the drug is approved in the EU, Australia, Mexico and more than ten other nations in addition to the US.
Ian Read, chairman and chief executive officer at Pfizer, said: "This approval is representative of Pfizer's dedication to discovering and bringing to market life-changing medicines and vaccines."
This comes after the company published positive clinical trial data last month showing the efficacy of its overactive bladder treatment Toviaz among elderly patients.
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Story collated for Zenopa by the Axonn News Agency