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Veyvondi (EU), Vonvendi (US) Prophylactic treatment in adults with von Willebrand disease

Information

Veyvondi (EU), Vonvendi (US)
Licence extension / variation
Takeda
Takeda

Development and Regulatory status

None
Pre-registration (Filed)
Pre-registration (Filed)
Yes
Nov 21This product is no longer an orphan medicine in the EU. It was originally designated an orphan medicine on 26 November 2010. Veyvondi was withdrawn from the Community register of orphan medicinal products in July 2018 upon request of the marketing authorisation holder [6].
May 21Filed in the US and EU [5].
Sep 19Has orphan drug status in EU & US [3].

Category

Blood-coagulation-factor
Affects <2 in 10,000 people in the EU - fewer than 101,000 people in total [2].
Prophylactic treatment in adults with von Willebrand disease
Intravenous

Trial or other data

Jul 20PIII study (NCT02973087) completed, no results have yet been published [4]
Mar 18PIII study (NCT02973087) is recruiting [1].
Dec 17PIII study to to investigate the efficacy and safety, including immunogenicity and thrombogenicity of prophylactic treatment with recombinant von Willebrand factor (rVWF) in subjects with severe von Willebrand disease (VWD) starts (NCT02973087). 22 adults will be recruited in the US, France, Germany, Italy, Netherlands, Russia, Spain and Turkey. Collection of primary outcome data (annualized bleeding rate [ABR] for spontaneous (not related to trauma) bleeding episodes) is due to complete May 19 [1].

Veyvondi (EU), Vonvendi (US) Severe von Willebrand disease in children aged up to 17 years - on-demand treatment of non-surgical and surgical (elective and emergency) bleeding episodes

Information

Veyvondi (EU), Vonvendi (US)
Licence extension / variation
Takeda
Takeda

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Yes

Category

Blood-coagulation-factor
Affects <2 in 10,000 people in the EU - fewer than 101,000 people in total [2].
Severe von Willebrand disease in children aged up to 17 years - on-demand treatment of non-surgical and surgical (elective and emergency) bleeding episodes
Intravenous