Biogen and Swedish Orphan Biovitrum AB (Sobi) have received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to market Elocta.
Elocta is a new medication for the treatment of hemophilia. Should the product be approved, it would mark the first time a hemophilia A treatment with prolonged circulation was available in the European Union.
"The CHMP’s recommendation to approve Elocta is an important milestone in potentially bringing this innovative therapeutic option to people with hemophilia A across Europe,” Aoife Brennan, M.D, vice president of Hematology, Clinical Development at Biogen, said.
The recommendation came after a Phase 3 A-LONG clinical study that evaluated the efficacy, safety and pharmacokinetics of the medication in previously-treated males 12 and older with severe hemophilia A.
“We are committed to bringing meaningful treatment advances to the hemophilia community in Europe and worldwide,” said Birgitte Volck, M.D., Ph.D., senior vice president of Development and chief medical officer of Sobi. “We welcome the news of this positive CHMP opinion and look forward to the EC’s forthcoming ELOCTA decision.”
Hemophilia A is a rare, chronic, genetic disorder in which the ability of a person’s blood to clot is impaired, due to missing or reduced levels of factor VIII protein.
Commonly reported adverse drug reactions to Elocta included arthralgia, malaise, myalgia, headache and rash.
