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Find Clinical Drug Pipeline Developments & Deals by Octapharma
Wilate (von Willebrand factor and coagulation factor VIII) promotes platelet aggregation and platelet adhesion on damaged vascular endothelium for the treatment and control of bleeding episodes and perioperative management of bleeding.
Lead Product(s):
Human Von Willebrand Factor/Coagulation Factor VIII Complex
Octaplas® is human pooled plasma for infusion of pharmaceutical grade with standardised quality and unique safety profiles used for indications such as in hepatic failure or massive transfusion, substitution therapy in coagulation factor deficiencies etc.
wilate® (human von willebrand factor/coagulation factor VIII complex) is a high-purity human VWF/FVIII concentrate, that undergoes two virus inactivation steps during its production. No albumin is added as a stabiliser.
Lead Product(s):
Human Von Willebrand Factor/Coagulation Factor VIII Complex
Octagam (human immune globulin) 10% is a liquid preparation of highly purified human immunoglobulin for intravenous administration. The results of the study demonstrated that octagam® 10% is an efficacious and well-tolerated treatment for adults with dermatomyositis.
OCTA101, (a human-cl rhFVIII and recombinant human von Willebrand Factor fragment dimer/OCTA8) a recombinant FVIII developed for subcutaneous administration in adult patients with severe haemophilia A.
U.S. FDA Office of Orphan Products Development has awarded seven years of marketing exclusivity for Octagam® 10%, the first and only intravenous immunoglobulin (IVIg) to be indicated for the treatment of adult dermatomyositis.
NUWIQ is a recombinant antihemophilic factor [coagulation factor VIII] indicated in adults and children with Hemophilia A for treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.
MOTIVATE trial comprised regimens of human cell line-derived recombinant FVIII Nuwiq® or the plasma-derived FVIII products octanate® or wilate® for the management of patients with hemophilia A and inhibitors.
The supplement approvals resulted in new product labeling for Octaplas™, Pooled Plasma (Human), Solvent/Detergent (S/D) Treated Solution for Intravenous Infusion, and fibryga®, Fibrinogen (Human) Lyophilized Powder for Reconstitution.
The NuProtect study was a prospective, multinational, open-label, non-controlled phase III study initiated in March 2013 to assess the immunogenicity, efficacy and safety of Nuwiq®.