BioCentury
ARTICLE | Politics & Policy

EMEA adding recombinant Factor VIII warning

August 1, 2007 2:15 AM UTC

EMEA said it will add a warning of neutralizing antibodies to the summary of product characteristics for all recombinant Factor VIII (rFVIII) products marketed in the EU for hemophilia A. The warning follows an agency review of data collected since 2003 from clinical trials, post-marketing studies and input from healthcare professionals and consumers of rFVIII products. Each rFVIII product will carry a warning that will say: "Cases of recurrence of inhibitors (low-titre) have been observed after switching from one recombinant factor VIII product to another in previously treated patients with more than 100 exposure days who have a history of inhibitor development." The agency did say that there was no need to change established treatment regimens with the products. ...