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Octapharma’s Wilate® Receives Expanded Approval from FDA

October 10, 2019
Octapharma’s Wilate® Receives Expanded Approval from FDA

Octapharma recently announced that their plasma-derived von Willebrand Factor (VWF)/Factor VIII (FVIII) product Wilate®, was approved by the U.S. Food and Drug Administration for the treatment of adults and adolescents with hemophilia A. The expanded indication is for routine prophylaxis to reduce the frequency of bleeding episodes and on demand treatment and control of bleeding episodes. Wilate® first received FDA approval 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.

According to a new Octapharma press release the approval was based on a series of clinical trials including a total of 136 previously treated patients with hemophilia A (aged 11 to 66 years). Trial participants received a Wilate® via five clinical studies that focused on prophylactic use, treatment on demand, surgery and/or pharmacokinetics. In all, subjects received 19,317,004 International Units (IU) of Wilate® during 9,001 exposure days. The most common adverse reaction was pyrexia (fever), in two subjects (1.5%). Further adverse reactions included pruritus (severe skin itch), headache and a sleeping disorder in  one subject (0.75%). Two out of 55 subjects (3.6%) in the pivotal study of routine prophylaxis in severe hemophilia A experienced an unexplained  and transient worsening of a pre-existing condition called thrombocytosis, in which the body produces too many platelets.

“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.”

Source: Octapharma press release dated October 9, 2019