The Times Australia
PR Newswire

.

Octapharma AG: Final data from the NuProtect study published on the immunogenicity of Nuwiq® in previously untreated patients with severe haemophilia A

Octapharma AG: Final data from the NuProtect study published on the immunogenicity of Nuwiq® in previously untreated patients with severe haemophilia A

LACHEN, Switzerland, Feb. 23, 2021 /PRNewswire/ -- Octapharma announced today that the final results from the NuProtect study on the immunogenicity of Nuwiq® in previously untreated patients (PUPs) with severe haemophilia A have been published in the leading medical journal Thrombosis and Haemostasis (Liesner RJ et al. "Simoctocog Alfa (Nuwiq®) in Previously Untreated Patients with Severe Haemophilia A: Final Results of the NuProtect Study" https://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0040-1722623[1]). 

The NuProtect study (NCT01712438; EudraCT 2012-002554-23) was a prospective, multinational, open-label, non-controlled phase III study initiated in March 2013 to assess the immunogenicity, efficacy and safety of Nuwiq®. The study recruited patients of any age and ethnicity at 38 sites in 17 countries and followed patients for 100 exposure days or up to 5 years. With enrolment of 110 patients, the NuProtect study was the largest clinical study to investigate a single product in true PUPs.

Of 105 evaluable PUPs with severe haemophilia A who received Nuwiq® for the prevention and treatment of bleeding:

  • 16.2% (17/105) of patients developed high-titre inhibitors
  • 10.5% (11/105) of patients developed low-titre inhibitors, five of which were transient
  • 26.7% (28/105) of patients developed any inhibitor

"The NuProtect study showed that there was a low risk of inhibitor development in PUPs starting treatment with Nuwiq®," commented Dr Ri Liesner, coordinating investigator of the NuProtect study and clinician at Great Ormond Street Hospital for Children in London, UK. "These data indicate Nuwiq® may be an attractive option for people newly diagnosed with severe haemophilia A, who are young children and represent a vulnerable patient subset."

The development of inhibitors to replacement factor VIII (FVIII) is a concern for doctors, as well as for patients and their families, particularly when first starting treatment. Inhibitors render FVIII therapy ineffective and limit treatment options.

These data complement the wealth of clinical experience in patients with haemophilia A receiving Nuwiq® for the treatment and prevention of bleeding.

"Nuwiq® was developed in a human cell line with the aim of minimising inhibitor risk in PUPs,said Larisa Belyanskaya, Head of Octapharma's IBU Haematology. "We are pleased to be able to share these positive data, which reflect this aim and which we hope will contribute to addressing this key treatment challenge."

"We know that haemophilia A patients face a lifetime of treatment decisions," commented Olaf Walter, Board Member at Octapharma. "These data highlight the potential of Nuwiq® to reassure PUPs and their families as they start their treatment. This publication brings us closer to Octapharma's goal of enabling all patients to lead healthy lives."

Earlier this year the FDA approved the inclusion of the immunogenicity data from the NuProtect study in the Nuwiq® Prescribing Information. Further publications on other analyses from the NuProtect study are planned.

Professor Anthony Chan, a co-author of the publication and Professor of Paediatrics at McMaster University, Canada, said: "Congratulations and thanks to Octapharma for developing Nuwiq, sponsoring the trial and providing a very good therapy for patients with haemophilia A."

Octapharma would also like to extend thanks to all participating centres, as well as patients and their caregivers, for their contribution to the study.

About Nuwiq®

Nuwiq® (simoctocog alfa) is a 4th generation recombinant factor VIII (rFVIII) protein, produced in a human cell line without chemical modification or fusion with any other protein1. It is cultured without additives of human or animal origin, is devoid of antigenic non-human protein epitopes and has a high affinity for von Willebrand factor1. Nuwiq® treatment has been assessed in seven completed clinical trials which included 201 previously treated patients (PTPs; 190 individuals) with severe haemophilia A, including 59 children1. Nuwiq® is available in 250 IU, 500 IU, 1000 IU, 2000 IU, 2500 IU, 3000 IU and 4000 IU presentations2. Nuwiq® is approved for use in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital FVIII deficiency) across all age groups2.

1.  Lissitchkov T et al. Ther Adv Hematol 2019; 10:2040620719858471.2.  Nuwiq® Summary of Product Characteristics.

About Haemophilia A

Haemophilia A is an X-linked hereditary bleeding disorder caused by a deficiency of factor VIII (FVIII) which, if left untreated, may lead to haemorrhages in muscles and joints and consequently to arthropathy and severe morbidity. The disorder affects around one in every 10,000 males worldwide. Prophylaxis with replacement FVIII therapy reduces the number of bleeding episodes and the risk of permanent joint damage. 

About Octapharma

Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines.

Octapharma employs more than 9,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Haematology, Immunotherapy, and Critical Care.

Octapharma has seven R&D sites and six state-of-the-art manufacturing facilities in Austria, France, Germany, Mexico and Sweden, and operates more than 160 plasma donation centres across Europe and the USA.

Logo: https://mma.prnasia.com/media2/1442016/Octapharma_Logo.jpg?p=medium600[2]  

Read more https://www.prnasia.com/story/archive/3286511_AE86511_0

Business Times

Understanding Energy Use Patterns by Season

Australia’s climate changes noticeably across the year. These seasonal changes don’t just affect what we wear or how we trave...

How Businesses Turn Data into Actionable Insights

In today's digital landscape, businesses are drowning in data yet thirsting for meaningful direction. The challenge isn't...

Ricoh Launches IM C401F A4 Colour MFP to Boost Speed and Security…

Ricoh, a leading provider of smart workplace technology, today launched the RICOH IM C401F, an enterprise-grade A4 colour d...

The Times Features

How to Choose a Cosmetic Clinic That Aligns With Your Aesthetic Goals

Clinics that align with your goals prioritise subtlety, safety, and client input Strong results come from experience, not trends or treatment bundles A proper consultation fe...

7 Non-Invasive Options That Can Subtly Enhance Your Features

Non-invasive treatments can refresh your appearance with minimal downtime Options range from anti-wrinkle treatments to advanced skin therapies Many results appear gradually ...

What is creatine? What does the science say about its claims to build muscle and boost brain health?

If you’ve walked down the wellness aisle at your local supermarket recently, or scrolled the latest wellness trends on social media, you’ve likely heard about creatine. Creati...

Whole House Water Filters: Essential or Optional for Australian Homes?

Access to clean, safe water is something most Australians take for granted—but the reality can be more complex. Our country’s unique climate, frequent droughts, and occasional ...

How Businesses Turn Data into Actionable Insights

In today's digital landscape, businesses are drowning in data yet thirsting for meaningful direction. The challenge isn't collecting information—it's knowing how to turn data i...

Why Mobile Allied Therapy Services Are Essential in Post-Hospital Recovery

Mobile allied health services matter more than ever under recent NDIA travel funding cuts. A quiet but critical shift is unfolding in Australia’s healthcare landscape. Mobile all...