Takeda Launches Adynovate To Advance Prophylaxis Treatment For Hemophilia Patients in India

Key highlights of ‘PROPEL’ study reveals1:

42% patients achieved zero bleeds with Adynovate (1-3% clotting factor level)
65% patients achieved zero spontaneous joint bleeds with Adynovate (1-3% clotting factor level)
>75% patients needed similar or lower Adynovate consumption with personalized prophylaxis using MyPKFit® vs. standard prophylaxis

‘CONTINUATION’ study confirmed sustained efficacy with ADYNOVATE treatments for > 2 years of observation2:

The hemophilia A patients on twice-weekly fixed-dose prophylaxis had very low bleeding tendency (spontaneous ABR was 1.20 among 186 patients)
Most patients experienced better joint health

Overall efficacy in controlling the bleed was rated good or excellent in 88.5%

Takeda Launches Adynovate To Advance Prophylaxis Treatment For Hemophilia Patients in with the launch of Adynovate, an innovative extended half-life recombinant Factor VIII (rFVIII) treatment, using established technology (controlled PEGylation), for hemophilia A patients.

Adynovate in combination with MYPKFIT®, first and only FDA approved application offers personalized and interactive prophylaxis treatment option that enables both healthcare professionals (HCPs) and patients in real-time monitoring of factor VIII levels from the comfort of their homes on phone thereby adapting their activity decisions accordingly and help improve their quality of life. Alerts are sent to patients on prophylaxis when their estimated factor VIII levels are low, and reminds them when their infusions are due, thereby providing excellent prophylactic coverage.

Speaking at the launch, Serina Fischer, General Manager – India, Takeda said, “Patients are at the core of every decision at Takeda and we are committed to increasing the access of our highly innovative treatments that enhances the quality of life for patients here in India. The launch of Adynovate is yet another step to address the gaps in hemophilia treatment and to assist the healthcare professionals and patients in better management of the condition. We are hopeful that this new treatment offering will help redefine possibilities for hemophilia patients in India.” Commenting on the benefits of prophylaxis for hemophilia A patients, Dr. Sandeep Arora, Head of Medical Affairs and Patient Services - India, Takeda*, said, “Individuals with severe hemophilia A have recurrent hemarthrosis, fragmentation of joint cartilage, bone destruction, and crippling which can be effectively reduced through prophylaxis as opposed to on-demand therapy. Studies show that an innovative extended half-life, Adynovate, helps patients to reduce dosing and infusion frequency thereby improving treatment adherence while providing personalized prophylactic coverage. Adynovate has been tested in comprehensive global clinical program demonstrating favorable safety and efficacy results that offer effective bleed resolution, better joint health, and almost ZERO spontaneous bleeds in majority” Administered in three steps with BAXJECT III™ system, Adynovate eliminates the need to disinfect the

Hyderabad,

May 23rd 2022: Takeda Pharmaceutical Company Limited, a global values-based, R&D-driven biopharmaceutical leader expanded its innovative rare diseases portfolio in India Administered in three steps with BAXJECT III™ s ystem, Adynovate eliminates the need to disinfect the

vial, as vials are already assembled in the system housing. It can be stored at room temperature not to exceed 30°C (86°F) for a period of up to 3 months not to exceed the expiration date thereby easing the handling and storing process.

As a global leader in pharmaceuticals, Takeda Pharmaceutical Company Limited has been focused on driving

comprehensive research to support the development of effective and innovative treatments in the company’s chosen therapy areas. Takeda India is part of Takeda Pharmaceutical Company Limited's group of companies headquartered in Japan. The company focuses on hematology, genetic diseases, immunology, and gastrointestinal portfolios in the country.

Ref:

1. Rurioctocog alfa pegol PK-guided prophylaxis in hemophilia A: results from the phase 3 PROPEL study, Robert Klamroth et al, Blood (2021) 137 (13): 1818–182(Link: https://doi.org/10.1182/blood.2020005673).

2. Long-term safety and efficacy results from the phase 3b, open-label, multicentre Continuation study of rurioctocog alfa pegol for prophylaxis in previously treated patients with severe haemophilia A, P Chowdary et al, Wiley Journal, Vol 26, Issue 4, July, 2020.

(Link: https://doi.org/10.1111/hae.14052)