Takeda Pharmaceutical Company’s US-based global research and development organization, Takeda Global Research & Development Center Inc. obtained fast track designation from the US Food and Drug Administration for Takeda's investigational compound TAK-242, which is a treatment for severe sepsis.
Sepsis is systemic inflammatory response syndrome (SIRS) caused by infection and excessive systemic response of host to bacteria and their toxins, with the symptoms such as high fever and increases in respiratory rates, and severe sepsis is defined as sepsis associated with organ dysfunction, such as renal, respiratory and cardiovascular organs etc., with high mortality rate.
TAK-242 suppresses production of inflammatory mediators such as cytokine by inhibiting the signal transduction through Toll-like receptor 4 (TLR4) which is one of the receptors recognizing the bacterial components.
Takeda submitted an application for fast track designation of TAK-242 to the FDA in May this year and received a designation for the treatment of severe sepsis as TAK-242 meets the criteria of "treating serious or life-threatening conditions and demonstrating the potential to address unmet medical needs."
In addition, phase I studies of TAK-242 were conducted in Japan, the US and Europe, and Takeda plans to start one pivotal global Phase 3 study in US, EU and Japan jointly, which are scheduled to start in this August, based on the discussion with both FDA and Pharmaceuticals and Medical Devices Agency (Japan).
"Severe sepsis is a really life-threatening disease and is one of the main causes of death in the intensive care unit (ICU), and there is no drug widely indicated for the severe sepsis patients," said Yasuchika Hasegawa, president & COO of Takeda.
"Through clinical studies which will start soon, we expect to confirm the efficacy of this compound as early as possible to provide a life-saving treatment option for this disease, which I believe will lead to realization of our management mission to strive toward better health for individuals and progress in medicine by developing superior pharmaceutical products," he added.