drugset
Drugs / BIVV001
last change Sep 2020 re-read 3 minutes ago

BIVV001

also known as rFVIIIFc-VWF-XTEN

Protein / enzyme biologic

Developed for
hemophilia A
Investigated by
Bioverativ, a Sanofi company

Trials 1

today NCT03205163 · Ph 1/2
2018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/2 NCT03205163 Aug 2017 → Nov 2018 hemophilia A Bioverativ, a Sanofi company Completed Met primary

Press releases naming this drug 3 releases

DateIssuerRelease
2020-09-10 Sobi, Inc. New England Journal of Medicine publishes positive final results from phase 1/2a study of BIVV001 in people with severe haemophilia A sobi.com ↗
2020-09-10 Sanofi New England Journal of Medicine publishes positive final results from Phase 1/2a study of BIVV001 in people with severe hemophilia A sanofi.com ↗
2019-12-11 Sobi, Inc. First patient dosed in BIVV001 phase 3 XTEND-1 study in people with severe haemophilia A sobi.com ↗

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as BIVV001 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03205163 ↗
Known as rFVIIIFc-VWF-XTEN “BIVV001 (rFVIIIFc-VWF-XTEN) is a novel fusion protein designed to overcome this half-life ceiling and maintain high sustained factor VIII activity levels.” PMID 32905674 ↗ Sep 2020
Action Restore “BIVV001 Fusion Protein as Factor VIII Replacement Therapy for Hemophilia A.” PMID 32905674 ↗ Sep 2020
Modality Protein / enzyme biologic “BIVV001 (rFVIIIFc-VWF-XTEN) is a novel fusion protein” PMID 32905674 ↗ Sep 2020
Route Intravenous “The patients then received a single intravenous injection of BIVV001 at the same corresponding dose of either 25 IU or 65 IU per kilogram.” PMID 32905674 ↗ Sep 2020