News

First Hemophilia A Patient Enrolls in Phase 4 Trial for Eloctate Immune Tolerance Induction

Swedish Orphan Biovitrum (Sobi) announced the successful enrollment of the first hemophilia A patient in the company’s ReITIrate clinical trial. The Phase 4 study (NCT03103542), sponsored in collaboration with Bioverativ Therapeutics, is actively recruiting participants who have developed inhibitors and who have failed to respond to other therapies. Researchers…

Eloctate Improves Joint Health in Hemophilia A, Phase 3 Study Shows

Interim results from the Phase 3 ASPIRE study indicate that patients with hemophilia A showed continuous improvement in joint health for nearly three years while receiving prophylactic dosing of Bioverativ and Sobi’s Eloctate. The interim results were reported in a study titled, “Improved joint health in subjects with severe haemophilia A…

BioMarin’s Investigative Gene Therapy for Hemophilia A Wins FDA Breakthrough Designation

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to BioMarin Pharmaceutical’s investigative therapy, valoctocogene roxaparvovec to treat patients with hemophilia A. This new status is likely to speed up the development and regulatory review of valoctocogene roxaparvovec, which has already received an Orphan Drug Designation from both…