FDA approves first recombinant von Willebrand factor to treat bleeding episodes

The US Food and Drug Administration late Tuesday announced it has approved Vonvendi, (von Willebrand factor [Recombinant]), for use in adults 18 years of age and older who have von Willebrand disease (VWD).

Developed and to be marketed by Baxalta (NYSE: BXLT), Vonvendi is the first FDA-approved recombinant von Willebrand factor, and is approved for the on-demand (as needed) treatment and control of bleeding episodes in adults diagnosed with VWD.  Baxalta shares were up nearly 3% at $36.80 on Tuesday.

VWD is the most common inherited bleeding disorder, affecting approximately 1% of the US population. Men and women are equally affected by VWD, which is caused by a deficiency or defect in von Willebrand factor, a protein that is critical for normal blood clotting. Patients with VWD can develop severe bleeding from the nose, gums, and intestines, as well as into muscles and joints. Women with VWD may have heavy menstrual periods lasting longer than average and may experience excessive bleeding after childbirth.