Aptevo’s Ixinity Found Safe and Effective in Children Under 12

Aptevo Therapeutics has announced that data from its ongoing Phase III clinical trial of Ixinity recombinant factor IX shows that the product is safe and effective in children under 12.  Ixinity is currently approved for treatment of patients 12 and older.  The study followed twelve children younger than 12 over time, most on prophylaxis.  The median annualized bleeding rate was 0.3.  The product was generally well-tolerated and no inhibitor development was observed.  Aptevo will continue the study with the aim of extending their approval to children under 12.