– Nine abstracts across Takeda's hematology portfolio and pipeline demonstrate Takeda's commitment to patient-centric, innovative care that aims to drive greater treatment outcomes
– Includes data exploring
– Nine abstracts across Takeda's hematology portfolio and pipeline demonstrate Takeda's commitment to patient-centric, innovative care that aims to drive greater treatment outcomes
– Includes data exploring ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated] in previously untreated patients (PUPs) with severe hemophilia A and an exploratory joint health biomarker analysis of the PROPEL study
– Design of a phase 3b clinical study will be published. The study will evaluate the safety and efficacy of TAK-755: the first and only investigational rADAMTS13 replacement therapy in clinical development.
– Design of the first clinical study examining TAK-755's therapeutic potential in sickle cell disease (SCD)
Takeda Pharmaceutical Company Limited ((TAK) ("Takeda") today announced the presentation of nine company-sponsored abstracts at the 63rd American Society of Hematology (ASH) Annual Meeting being held December 11-14, 2021 in Atlanta, Georgia and virtually. The abstracts span Takeda's extensive hematology portfolio and research and development (R&D) pipeline, featuring data on multiple products and investigational candidates, supporting Takeda's commitment to helping healthcare professionals improve the way they treat patients as well as delivering innovative solutions for the future.
"At Takeda, we are advancing a promising pipeline of potentially transformative molecules for multiple rare and life-threatening hematological disorders, while also expanding the body of evidence to support our current portfolio of treatments for people living with rare bleeding disorders," said Neil Inhaber, Head, Global Medical Affairs, Rare Genetics and Hematology. "The data presented at this year's ASH annual meeting demonstrate Takeda's commitment to advancing the science in hematology and personalized treatment strategies that aim to address many different needs within the bleeding disorders community."
Highlights of data to be presented during ASH include:
ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated] data in previously untreated patients with severe hemophilia A
Data from the first prospective study evaluating the safety, immunogenicity, and efficacy of ADYNOVATE in previously untreated patients (PUPs), including those younger than six years old, with severe hemophilia A will be presented [Abstract #3184].1
Analysis of joint health from the PROPEL study
Takeda will present post-hoc data from a randomized clinical trial in severe hemophilia A patients on FVIII prophylaxis —the PROPEL study. Six different biomarkers of joint health were measured in 98 patients before and after prophylactic treatment with ADYNOVATE [Abstract #2102].2
This novel biomarker data is the first in a randomized clinical trial to understand the importance of prophylaxis for joint health in patients with hemophilia A, as well as the first study examining longitudinal biomarker levels in a prospective randomized study of severe hemophilia A patients undergoing FVIII prophylaxis at two trough levels (1-3% and 8-12%) to examine the correlation between clinical outcomes and surrogate markers. The results also showed improvement in specific biomarker levels from baseline to study completion [Abstract #2102].2
A cost analysis of prophylaxis with factor VIII replacement and emicizumab in real-world settings
Real-world evidence (RWE) allows healthcare professionals to better understand how medications work in routine clinical practice, potentially advancing patient-centric treatment, particularly in hematological disorders. Takeda is presenting real-world data extracted from the IQVIA PharMetrics® Plus database (2015-2020), a longitudinal U.S. commercial health plan database, analyzing prophylaxis with factor VIII (FVIII) replacement and emicizumab in billed annualized bleed rate and all-cause cost of switching from FVIII to emicizumab [Abstract #3028].3
"This real-world study helps to illuminate important therapeutic and cost impacts of different treatment options for patients with hemophilia A," commented study author, Katharine Batt, MD, MSc. "These findings are incredibly important for healthcare providers, as the data can begin to help them better understand different treatment options, the long-term implications of use and the best treatment fit for their patients, thereby offering a more personalized form of patient care."
Design of studies further exploring the therapeutic potential of recombinant ADAMTS13 replacement (TAK-755) in cTTP and sickle cell disease (SCD)
Takeda is continuing to assess the potential of TAK-755, a recombinant ADAMTS13 replacement therapy, in patients with severe cTTP, an ultra-rare and potentially life-threatening ADAMTS13 deficiency driven thrombotic disorder.4 The design of a phase 3b open-label continuation study that aims to evaluate the long-term safety and efficacy of TAK-755 for prophylactic and on-demand treatment of severe cTTP will be made available in the ASH program [accepted for online publication only].4
Takeda will also present the design of the first phase 1 study assessing safety, tolerability, pharmacokinetics, and pharmacodynamics of recombinant ADAMTS13 (TAK-755) in patients with SCD [Abstract #3118].5
rADAMTS13 (TAK-755), is an investigational compound that has not been approved for use by U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or any other regulatory authorities.
The Takeda Hematology team is proud to, once again, have a significant presence at ASH along with Takeda Oncology. A full list of all company-sponsored abstracts can be found here.
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