EC OKs Wyeth ReFacto MA variation

US drug major Wyeth' UK subsidiary has received a positive decision from the European Commission for a variation of the marketing authorization  for ReFacto moroctocog alfa (recombinant coagulation Factor VIII), a  treatment for hemophilia A. The manufacturing process for ReFacto has  been modified, and the name has been changed to ReFacto AF moroctocog  alfa. The decision by the EC follows a positive recommendation from the  Committee for Medicinal Products for Human Use (CHMP) on December 18,  2008.

ReFacto AF - indicated for the treatment and prophylaxis of bleeding in  adults and children of all ages with hemophilia A - is a recombinant  factor VIII product free of added exogenous human- or animal-derived  protein in its cell culture, manufacturing, purification processes and  final formulation.

"This milestone is an important step in the evolution of hemophilia A  treatment and establishes a new standard in recombinant factor VIII  product purification," says Andreas Krebs, president, Wyeth Europe. "We  believe the state-of-the-art manufacturing and purification process used  for ReFacto AF make it an exciting new therapeutic option for many  patients with hemophilia A," he added.