Octapharma USA issued the following announcement on Oct. 8.
Octapharma USA announced the U.S. Food and Drug Administration (FDA) has approved WILATE® for treatment of adults and adolescents with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes and on demand treatment and control of bleeding episodes.
WILATE® is a human plasma-derived, sterile, purified, double virus inactivated von Willebrand Factor (VWF)/coagulation Factor VIII (FVIII) complex initially approved by the FDA in 2009 for children and adults with von Willebrand Disease (VWD) for on-demand treatment and control of bleeding episodes; and perioperative management of bleeding. The FDA approved Octapharma’s application to add the hemophilia A indication based on the results of the “Clinical Study to Investigate the PK, Efficacy, and Safety of Wilate in Patients With Severe Hemophilia A,” (ClinicalTrials.gov Identifier: NCT02954575).
“Octapharma has been committed to providing U.S. hemophilia A patients with complete access to the company product portfolio since our inception,” said Octapharma USA President Flemming Nielsen. “We are excited for providers and patients who have been looking forward to the day when WILATE® would be indicated for hemophilia A. Octapharma is dedicated to providing the bleeding disorders community with the therapies and programs that enhance patient lives every day.”
A total of 136 previously treated patients with hemophilia A (aged 11 to 66 years) received WILATE® in five clinical studies that involved prophylactic use, treatment on demand, surgery and/or pharmacokinetics. All subjects were male. Overall, subjects received 19,317,004 International Units (IU) of WILATE® during 9,001 exposure days. The most common adverse reaction was pyrexia (two subjects; 1.5%). Further adverse reactions included pruritus, headache and sleeping disorder (one subject; 0.75%). Two out of 55 subjects (3.6%) in the pivotal study of routine prophylaxis in severe hemophilia A had unexplained transient worsening of pre-existing thrombocytosis while on the study.1
About WILATE®
WILATE®, von Willebrand Factor/Coagulation Factor VIII Complex (Human) Lyophilized Powder for Solution for Intravenous Injection, is indicated in children and adults with von Willebrand disease for on-demand treatment and control of bleeding episodes; and perioperative management of bleeding. WILATE® is indicated in adolescents and adults with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes; and on-demand treatment and control of bleeding episodes. For complete prescribing information, please visit wilateusa.com.
CONTRAINDICATIONS
Do not use in patients with known hypersensitivity reactions, including anaphylactic or severe systemic reaction, to human plasma-derived products, any ingredient in the formulation, or components of the container.
WARNINGS AND PRECAUTIONS
Anaphylaxis and severe hypersensitivity reactions are possible; thromboembolic events may occur; monitor plasma levels of FVIII activity; development of neutralizing antibodies to FVIII and to VWF, especially in VWD type 3 patients, may occur; WILATE® is made from human plasma and carries the risk of transmitting infectious agents.
About the Octapharma Group
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation since 1983. Its core business is the development and production of human proteins from human plasma and human cell lines. Octapharma employs approximately 8,314 people worldwide to support the treatment of patients in over 115 countries with products across the following therapeutic areas: Hematology (coagulation disorders), Immunotherapy (immune disorders) and Critical Care. The company’s American subsidiary, Octapharma USA, is located in Hoboken, N.J. Octapharma operates three state-of-the-art production sites licensed by the U.S. Food and Drug Administration (FDA), providing a high level of production flexibility. For more information, please visit www.octapharmausa.com.
Original source can be found here.
