FDA approves Wilate for haemophilia A.- Octapharma

Octapharma USA announced the 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.

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). 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.