FDA approves Baxalta's Vonvendi for von Willebrand bleeding disorder
- Baxalta's Vonvendi is the first FDA-approved recombinant von Willebrand factor. The agency approved the treatment on Tuesday.
- Von Willebrand disease (VWD) is the most common inherited bleeding disorder. The disease affects approximately 1% of the U.S. population.
- Vonvendi is approved for on-demand use to control bleeding episodes in adults who have VWD and are aged 18 and above.
Vonvendi is the second FDA-approved drug for the recently spun-off Baxalta. Less than one month ago, the FDA approved Adynovate (Antihemophilic Factor Recombinant, PEGylated) for use in patients with hemophilia A.
Vonvendi's approval provides another treatment option for patients with VWD, while also further raising Balxalta's stature in the hematology therapeutic area. The company's growing capability in this area should help consolidate its defensive stance against Shire.
As Baxalta racks up new drug approvals, the buy-out threat from Shire may be diminishing.