NUWIQ – Safety & Efficacy

POWERFUL BLEEDING CONTROL Prophylaxis With NUWIQ Markedly Reduced Bleeding Frequency2

In Clinical Trials of Standard Prophylaxis With NUWIQ in Adult (N=32) and Pediatric (N=59) Patients Treated for ≥6 Months2*

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ABR = annual bleeding rate.
* NUWIQ prophylaxis regimen: every other day or 3 times per week for ≥ 6 months.

All Patients Experienced Fewer Bleeds with NUWIQ Prophylaxis vs On-Demand Treatment With Another FVIII Product2,12†

Patients were switched from on-demand therapy (pre-study) with another FVIII product to prophylaxis with NUWIQ.

EFFECTIVE BLEEDING RESOLUTION
On-Demand Treatment Readily Controlled Bleeding2

effective bleeding resolution

NUWIQ Safety in PTPs1

  • NUWIQ was shown to be safe in clinical studies that included 135 previously treated patients (PTPs)
  • FVIII levels can be safely and accurately measured with both the chromogenic and one-stage assays
  • No serious or severe reactions to NUWIQ in clinical studies, and no deaths reported

Inhibitor Risk in Previously Untreated Patients (PUPs)

The incidence of inhibitors with rFVIII products made in hamster cells

Results from the SIPPET Study (Survey of Inhibitors in Plasma-Product Exposed Toddlers)3

  • The SIPPET study compared the rates of inhibitors in PUPs who were treated with either plasma-derived FVIII (pdFVIII) or recombinant FVIII (rFVIII) made from hamster cells
  • Results from the SIPPET study showed:
    PUPs treated with rFVIII from hamster cells had a 28.4% incidence of high-titer inhibitors
    PUPs treated with pdFVIII had a 18.6% incidence of high-titer inhibitors

SIPPET: High - Titer Inhibitors

in PUPs treated with rFVIII from hamster cells.

in PUPs treated with plasma-derived FVIII.

NUWIQ Safety in PUPs

  • The safety of NUWIQ in PUPs with severe Hemophilia A is being studied in a clinical trial called NuProtect.3
  • The trial will evaluate 110 PUPs, making NuProtect the largest prospective study with a single FVIII product.
  • In an interim analysis from NuProtect, data from 66 PUPs treated with NUWIQ was evaluated.
  • The interim data showed a 12.8% incidence of high-titer inhibitors*

NuProtect: High – Titer Inhibitors

in PUPs treated with NUWIQ®, made from human cells.

*Results are from an interim analysis of the NuProtect study and do not reflect final study results. These data have not been presented to the FDA for evaluation. Information from the NuProtect study is presented in parallel to the SIPPET study for context, but please note that these trials were performed under different conditions, with different populations, and are not “head to head” comparisons.

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NUWIQ offers convenient and flexible dosing for children and adults.

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References
  1. NUWIQ Full Prescribing Information. Hoboken, NJ: Octapharma; 2015.
  2. Data on file. Hoboken, NJ: Octapharma USA Inc; 2015
  3. Peyvandi F, Mannucci PM, Garagiola I, et al. N Engl J Med. 2016;374:2054-2064.
  4. Liesner R. et al. Immunogencity, efficacy and safety of NUWIQ (human-cl rhFVIII) in previously untreated patients with severe haemophilia A-interim results from the NuProtect Study. Haemophilia [submitted for publication].