FDA

FDA OKs expanded indications for Vonvendi

September 11, 2025

FDA approved expanded use of Vonvendi (von Willebrand factor [recombinant]) for routine prophylaxis in adults (≥18 years) with all types of von Willebrand disease (VWD) and on-demand and treatment of bleeding episodes and perioperative use in children with VWD.

Previously, Vonvendi was approved only for on-demand treatment of bleeding episodes and perioperative use in adults and prophylactic use only in adults with type 3 VWD, the most serious type.

Efficacy

Efficacy of Vonvendi was demonstrated in multiple clinical studies that showed success in treatment control of bleeding episodes and use in perioperative management in patients with VWD of all ages. It also proved successful for prevention of bleeding episodes in adults with VWD.

Safety

The most common adverse reactions observed in ≥2% of patients in clinical trials were headache, vomiting, nausea, dizziness, and generalized pruritus.

Sources:

FDA Approves Expanded Use of Vonvedi for von Willebrand Disease, Including for Certain Uses for Children [News release]. 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-expanded-use-vonvendi-von-willebrand-disease-including-certain-uses-children

US FDA approves expanded indication for Vonvendi® [von Willebrand factor (recombinant)] for adults and children with von Willebrand disease. [News release]. 2025. https://www.takeda.com/newsroom/newsreleases/2025/expanded-indication-vonvendi/

Vonvendi (von Willebrand factor [recombinant]) [package insert]. Takeda. https://www.shirecontent.com/PI/PDFs/VONVENDI_USA_ENG.pdf Revised September 2025. Accessed September 10, 2025.