wilate Clinical Evidence and Safety for VWD Treatment

wilate has been proven to be safe and effective
for the treatment of bleeding in VWD

The safety and effectiveness of wilate was tested in 4 different clinical studies. These studies included adult
and pediatric patients with mild, moderate, and severe VWD, and included more than 1,000 bleeding episodes.

Successful treatment of bleeding episodes in patients with VWD1,*+

*A “bleeding episode” may involve bleeding at multiple sites in this analysis. The most common bleeding sites were joints, nose bleeds, stomach bleeds, and mouth bleeds.
Among 70 VWD patients, 45 patients received wilate on-demand treatment for 1,068 bleeding episodes, including 11 pediatric patients (5-16 years of age), treated for 234 bleeding episodes.1

  • For all patients studied, 84% of bleeding treatments were successful
  • For pediatric patients studied, 88% of bleeding treatments were successful
  • 93% of the successfully treated bleeds occurred in type 3 patients, the most severe type of VWD

wilate is proven to be safe and effective in minor
and major surgery2

Success in prevention and treatment of bleeding

By type of surgery

Efficacy assessment*% Success
Minor (N-9)100% (9/9)
Minor (N-21)95.2% (20/21)
All surgeries (N-30)96.7% (29/30)

*Based on the derived overall assessment (derived from the intra- and postoperative assessment of the IDMC, based on blood loss, transfusion requirements, and postoperative bleeding and oozing). IDMC, Independent Data Monitoring Committee.
†Two patients were enrolled for 2 surgeries each; therefore, there were 28 individual patients

  • Efficacy was excellent or good in all surgical procedures with children (3 surgeries in 3 children)
  • There were no thromboembolic events

wilate safety and tolerability

In clinical trials, 92 VWD patients received 5,676 infusions of wilate 1

  • There were no reported cases of thrombotic events1
  • The most common adverse reactions were hypersensitivity (allergic) reactions, urticaria (hives),
    and dizziness (each in 2.2% of patients)
  • The most serious adverse reactions were hypersensitivity reactions.
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wilate Free Trial Program

Eligible patients can try wilate at no cost

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Reference:
  1. wilate Full Prescribing Information. Hoboken, NJ: Octapharma; rev 2016
  2. Srivastava A, et al. Haemophilia. 2017;23(2):264-272.
  3. Data on file. Hoboken, NJ: Octapharma USA Inc. 2018