Sanofi continues pediatric vaccine push with FDA Quadracel nod
The French drugmaker's new combo vaccine protects children aged 4 to 6 against diphtheria, tetanus, pertussis and polio (DTap-IPV), and it could help them complete the entire schedule of immunizations with as few injections as possible, David Greenberg, Sanofi's VP of U.S. scientific and medical affairs, said in a statement. Currently, the CDC recommends that children in the age range receive both their fifth dose of diphtheria, tetanus and acellular pertussis vaccine series and their fourth dose of inactivated poliovirus vaccine series, with Quadracel fitting both roles.
The approval was based on data from a Phase III study designed to compare the safety and immunogenicity of Quadracel with separately administered DTaP and polio vaccines, Sanofi said. The vaccine already has a green light in Canada and Australia.
The nod will help Sanofi's vaccines unit add to its €3.9 billion in 2014 revenue. The company was recently bumped from second to third place in global vaccines producers after GlaxoSmithKline ($GSK) acquired most of Novartis' ($NVS) stall of vaccines products, propelling it from third to first.
Having been identified as important to Sanofi's ($SNY) vaccines unit, any wins in pediatric vaccines are welcome news to the vaccine maker. In October last year, the FDA accepted the company's application for its hexavalent DTaP5-IPV-Hib-HepB1 candidate--protecting against diphtheria, tetanus, pertussis, polio, Hib and hepatitis B. If approved, it'll expand the company's stable alongside blockbuster Pentacel, which brought in $1.53 billion in 2013.
- read Sanofi's release