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Investigational Compound (TAK-242) for Severe Sepsis Designated as Fast Track Drugs from FDA, Takeda
Takeda Pharmaceutical Company Limited today announced that its US based global research and development
organization, Takeda Global Research & Development Center Inc. obtained on July 18
the fast track designation by the U.S. Food and Drug Administration ("FDA") 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."
http://www.takeda.co.jp
Cercetat, Compound (tak-242) pentru severe Sepsis desemnate ca rapide Droguri de la FDA, Takeda - Investigational Compound (TAK-242) for Severe Sepsis Designated as Fast Track Drugs from FDA, Takeda - articole medicale engleza - startsanatate