Factor VIII

also known as FVIII

Developed for: severe hemophilia A · von Willebrand disease (hereditary or acquired) · hemophilia A
Investigated by: Bio Products Laboratory · Hampshire Hospitals NHS Foundation Trust · University of Wales Cardiff United Kingdom (UK) · Uppsala University

Trials 2

today NCT02697370 · Ph 4 NCT00404300 · Ph 3

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 31 trial
Phase 3	NCT00404300	Feb 2007 → Sep 2008	von Willebrand disease (hereditary or acquired)	Bio Products Laboratory	Terminated	No outcome recorded Stop: Enrollment
Phase 41 trial
Phase 4	NCT02697370	Apr 2013 → May 2015	severe hemophilia A	Hampshire Hospitals NHS Foundation Trust	Completed	No outcome recorded
Comparator or background therapy3 trials
Phase 2/3	NCT06938659 Comparator	Jun 2025 → May 2026 overdue	hemophilia A	Dhaka Medical College	Not yet recruiting	No outcome recorded
Phase 3	NCT02847637 Background	Sep 2016 → Sep 2017	hemophilia A	Hoffmann-La Roche	Completed	Met primary
Phase 4	NCT01561391 Background	Apr 1998 → May 2004	congenital hematological disorder, hemophilia A, hemophilia B	Novo Nordisk A/S	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 4

Date	Issuer	Release
2022-11-03	Hoffmann-La Roche	Results Roche to present data at ASH 2022 showcasing strength of haematology portfolio and expanding into new areas to address more patient needs roche.com ↗ Long-Term Durable FVIII Expression with Improvements in Bleeding Rates Following AAV-Mediated FVIII Gene Transfer for Hemophilia A: Multiyear Follow-up on the Phase I/II Trial of SPK-8011
2018-02-27	Novo Nordisk A/S	Regulatory Novo Nordisk files for regulatory approval of long-acting factor VIII (N8-GP) in the US and the EU for treatment of haemophilia A novonordisk.com ↗ We are excited to file the regulatory application for long-acting N8-GP in the US and EU,
2014-03-19	Novo Nordisk A/S	Results Positive results from first phase 3 trial with N8-GP, a long-acting factor VIII for treatment of haemophilia A novonordisk.com ↗
2008-10-29	Kedrion S.p.A.	Results Nuovo metodo di purificazione di concentrato di Fattore VIII/FvW studio pubblicato sulla rivista Vox Sanguinis kedrion.co.uk ↗ Il lavoro sperimentale descritto nell’articolo ha permesso di mettere a punto un nuovo processo di purificazione del complesso fattore VIII/fattore von Willebrand con alta resa e purezza.

All press releases naming this drug 19 releases

Date	Issuer	Release
2022-11-03	Hoffmann-La Roche	Roche to present data at ASH 2022 showcasing strength of haematology portfolio and expanding into new areas to address more patient needs roche.com ↗
2019-03-14	Hoffmann-La Roche	European Commission approves Roche's Hemlibra for people with severe haemophilia A without factor VIII inhibitors roche.com ↗
2019-03-14	Chugai Pharmaceutical	Chugai’s Hemlibra Receives Approval for Severe Hemophilia A without Factor VIII Inhibitors from the European Commission chugai-pharm.co.jp ↗
2019-02-01	Hoffmann-La Roche	CHMP recommends EU approval of Roche's Hemlibra for people with severe haemophilia A without factor VIII inhibitors roche.com ↗
2018-12-04	Chugai Pharmaceutical	Chugai’s HEMLIBRA ® Approved in Taiwan for the Treatment of Hemophilia A with Factor VIII Inhibitors chugai-pharm.co.jp ↗
2018-12-03	Hoffmann-La Roche	Roche's Hemlibra provided sustained bleed control in the largest pivotal study to date of children with haemophilia A with factor VIII inhibitors roche.com ↗
2018-10-04	Genentech, Inc.	FDA Approves Genentech’s Hemlibra (Emicizumab-kxwh) for Hemophilia A Without Factor VIII Inhibitors gene.com ↗
2018-08-30	Hoffmann-La Roche	Positive phase III results for Roche's Hemlibra for haemophilia A without factor VIII inhibitors published in New England Journal of Medicine roche.com ↗
2018-08-29	Genentech, Inc.	Positive Phase III Results for Genentech’s HEMLIBRA® (emicizumab-kxwh) for Hemophilia A Without Factor VIII Inhibitors Published in New England Journal of Medicine gene.com ↗
2018-06-05	Hoffmann-La Roche	FDA grants Priority Review to Roche’s Hemlibra for people with haemophilia A without factor VIII inhibitors roche.com ↗
2018-06-04	Genentech, Inc.	FDA Grants Priority Review to Genentech’s HEMLIBRA (emicizumab-kxwh) for People With Hemophilia A Without Factor VIII Inhibitors gene.com ↗
2018-05-21	Hoffmann-La Roche	Roche’s Hemlibra reduced treated bleeds by 96 percent compared to no prophylaxis in phase III HAVEN 3 study in haemophilia A without factor VIII inhibitors roche.com ↗
2018-05-20	Genentech, Inc.	Genentech’s HEMLIBRA (emicizumab-kxwh) Reduced Treated Bleeds by 96 Percent Compared to No Prophylaxis in Phase III Haven 3 Study in Hemophilia A Without Factor VIII Inhibitors gene.com ↗
2018-04-26	Chugai Pharmaceutical	Chugai Files Applications for HEMLIBRA ® for the Treatment of Hemophilia A without Factor VIII Inhibitors and for Extension of Dosing Interval chugai-pharm.co.jp ↗
2018-04-17	Chugai Pharmaceutical	Chugai’s HEMLIBRA ® Receives Breakthrough Therapy Designation from U.S. FDA for Hemophilia A without Factor VIII Inhibitors chugai-pharm.co.jp ↗
2018-02-27	Novo Nordisk A/S	Novo Nordisk files for regulatory approval of long-acting factor VIII (N8-GP) in the US and the EU for treatment of haemophilia A novonordisk.com ↗
2017-07-21	Chugai Pharmaceutical	Chugai Files a New Drug Application for Its Bispecific Monoclonal Antibody “Emicizumab” for the Treatment of Congenital Factor VIII Deficiency (Hemophilia A) with Factor VIII Inhibitors chugai-pharm.co.jp ↗
2014-03-19	Novo Nordisk A/S	Positive results from first phase 3 trial with N8-GP, a long-acting factor VIII for treatment of haemophilia A novonordisk.com ↗
2008-10-29	Kedrion S.p.A.	Nuovo metodo di purificazione di concentrato di Fattore VIII/FvW studio pubblicato sulla rivista Vox Sanguinis kedrion.co.uk ↗

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 5 sources stand behind the page.

Field	Value	Cited text
Known as	Factor VIII	“The patient's current factor VIII product will be used.” NCT02697370 ↗ 4 “Plasma-derived Factor VIII” NCT00404300 ↗ NCT06938659 ↗ NCT01561391 ↗ NCT02847637 ↗
Known as	FVIII	“Factor VIII (FVIII)” NCT06938659 ↗ 1 “Factor VIII (FVIII)” NCT02847637 ↗
Action	Restore	“Factor VIII replacement therapy - non brand specific” NCT02697370 ↗
Modality	Protein / enzyme biologic	“factor VIII concentrate” NCT02697370 ↗