NUWIQ Proven Safe in PTPs and PUPs

NUWIQ Safety in Previously Treated Patients (PTPs)

If you or a member of your family has been living with Hemophilia A, you’ve gained valuable experience over the years with treating and managing all different kinds of bleeds. Joint bleeds, muscle bleeds – you’ve seen it all. And over the years, you’ve probably tried more than one FVIII product to find the one that works best for you. One that provides protection against bleeds, has proven safety and offers flexible dosing and easy administration. Having choices is good. And working with your doctor to choose a product that’s right for you is one of the most important decisions you’ll make.

Inhibitors after switching to NUWIQ

Zero Inhibitors with PTPs Who Switched to NUWIQ

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

Understanding Inhibitor Risk in Previously Untreated Patients (PUPs)

The development of inhibitors to plasma-derived FVIII (pdFVIII) or recombinant FVIII (rFVIII) is the most serious complication of therapy for patients with Hemophilia.4 Once inhibitors develop, they can significantly impair the effectiveness of FVIII treatment, making it more difficult to stop or prevent bleeding episodes.2 In most cases, inhibitor risk is directly related to the number of exposure days (EDs) during initial treatment with FVIII, often developing in the first 20 EDs.1

SIPPET: Incidence of inhibitors with rFVIII products made in hamster cells

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 (Survey of Inhibitors in Plasma-Product Exposed Toddlers)7

in PUPs treated with rFVIII from hamster cells

in PUPs treated with plasma-derived FVIII

NuProtect: NUWIQ Safety in PUPs2

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 early, or interim, analysis from NuProtect, data from 66 PUPs treated with NUWIQ was evaluated

Interim Data from NuProtect

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 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.

NUWIQ Provides Fewer Bleeding Episodes with Prophylaxis

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References
  1. Kannicht C, et al. Thromb Res. 2013;131:78-88.
  2. Iorio A, Puccetti P, Makris M. Clotting factor concentrate switching and inhibitor development in hemophilia A. Blood. 2012;120(4):720-727.
  3. CDC Inhibitor Fact Sheet.
  4. van den Berg HM. Different impact of Factor VIII production inhibitor development? Thrombosis J. 2016;14(suppl 1):55-58