EMA To Review Biogen's Hemophilia A Therapy
By Lori Clapper
Biogen Idec’s hemophilia A therapy is now under review by European regulatory authorities.
The company says the European Medicines Agency (EMA) accepted the marketing authorization application for review last week for the recombinant factor VIII Fc fusion protein known as Eloctra. It has been developed through a partnership with Swedish Orphan Biovitrum, or Sobi, according to a company announcement.
In its Phase 3 A-LONG clinical study, 165 males 12 years of age and older who suffer from severe hemophilia A were treated using individualized and weekly treatments aimed to reduce or prevent bleeding episodes, as well as “on-demand dosing” to treat bleeding episodes. For patients enrolled in the individualized treatment arm, the patients were treated twice weekly.
Final results of the clinical trial data demonstrated efficacy, safety, and pharmacokinetics and proved that the drug can treat both adult and pediatric patients, according to Zenopa.
"Elocta has the potential to protect against bleeding episodes while helping to address the challenge of frequent injections." Dr. Douglas Williams, EVP of research and development at Biogen Idec, said.
It is estimated that approximately 142,000 people worldwide are currently living with hemophilia A, according to the 2012 World Federation of Hemophilia global survey.
Hemophilia A is a rare but chronic genetic disorder that impairs the ability of a person’s blood to clot. This lack of clotting ability is due to missing or reduced levels of the protein factor VIII.
This news comes shortly after Biogen Idec announced in October 2014 that it appointed two leading neuroscientists to head the company’s neurodegenerative disease research. Christopher Henderson, Ph.D., will hold the position of VP, Neurology, while Richard Ransohoff, M.D., assumes the role as senior research fellow, Neuroimmunology.
Biogen Idec has been focused primarily on research on neurodegenerative and neuroimmune diseases, including Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis (ALS), and multiple sclerosis (MS). Both Henderson and Ransohoff will partner within Biogen Idec’s research and development organization to identify and advance the development of new drug products.