NUWIQ Proven Safe in PTPs and PUPs

NUWIQ Safety in Previously Treated Patients (PTPs)

As a person living with Hemophilia A, or a caregiver for a child or loved one, you probably know that the development of inhibitors can be a serious complication of factor VIII treatment. Once inhibitors develop, they can significantly impair the effectiveness of treatment, making it more difficult to stop or prevent bleeding episodes1.

In clinical studies with PTPs (N=135) who switched to NUWIQ, there were zero FVIII inhibitors after > 50 exposure days and > 6 months of treatment2,3

Zero Inhibitors with PTPs Who Switched to NUWIQ2,3

Inhibitors after switching to NUWIQ
  • Zero patients experienced serious or severe adverse drug reactions
  • Zero patients experienced anaphlylaxis, a very serious allergic reaction
  • Zero patients dropped out of the study because of adverse reactions
  • Zero deaths were reported

NUWIQ Safety in Previously Untreated Patients (PUPs)

Inhibitor risk is highest in previously untreated patients (or PUPS). In most cases, the risk is directly related to the number of exposure days (EDs) during initial treatment with FVIII, often developing in the first 20 EDs.4

  • The safety of NUWIQ® in PUPs with severe hemophilia A was studied in a clinical trial called NuProtect.5 The trial studied 105 PUPs, making NuProtect the largest prospective study with a single FVIII product*

Incidence of high-titer inhibitors in PUPs treated with NUWIQ, made from human cells5

*Results 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.

Incidence of inhibitors with rFVIII products made in hamster cells

NUWIQ is different from FVIII products made from hamster cells, because NUWIQ is derived
from human cells.2
The SIPPET study (Survey of Inhibitors in Plasma-Product Exposed Toddlers) compared the rates of inhibitors in PUPs who were treated with plasma-derived FVIII (pdFVIII) or recombinant FVIII (rFVIII) made from hamster cells.6*

Inhibitors in the SIPPET study (high-titer Inhibitors)

in PUPs treated with rFVIII from hamster cells

in PUPs treated with plasma-derived FVIII

NUWIQ Provides Fewer Bleeding Episodes with Prophylaxis

Efficacy
References
  1. Centers for Disease Control and Prevention. https://www.cdc.gov/features/inhibitors/index.html
  2. NUWIQ full Prescribing Information. Paramus, NJ: Octapharma USA, Inc.; rev 2017
  3. Data on file. Paramus, NJ: Octapharma USA, Inc; 2015.
  4. van den Berg, HM. Thrombosis Journal 2016, 14(Suppl 1):31 DOI 10.1186/s12959-016-0102-4./li>
  5. Ri Liesner, Ellis J. Neufeld; Inhibitor Development with Simoctocog Alfa in Previously Untreated Patients with Severe Haemophilia a: Final Results of the Nuprotect Study. Blood 2019; 134 (Supplement_1): 903. doi: https://doi.org/10.1182/blood-2019-125520
  6. Peyvandi F, et al. N Engl J Med. 2016;374:2054-2064.