Healthcare Industry News: U.S. Food and Drug Administration
News Release - September 26, 2018
Aronora's New Blood Clot Treatment Receives FDA Fast Track DesignationEnzyme that selectively targets blood clots has received FDA Fast Track designation, allowing for expedited clinical development
PORTLAND, Ore., Sept. 26, 2018 -- (Healthcare Sales & Marketing Network) -- Aronora Inc., a clinical stage biotechnology company developing first-in-class treatments for life-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for proCase (E-WE thrombin, AB002), an enzyme that is intended to reverse blood clot formation without increasing the risk of bleeding. Despite currently approved treatments, over one million people still die from blood clots every year in the U.S.
"We are incredibly excited about this FDA Fast Track designation, which will enable us to accelerate clinical development of proCase for patients with life-threatening blood clots, including those suffering from stroke and heart attack," said Erik Tucker, Co-founder and Chief Operating Officer of Aronora. "The last new clot-busting drug, tissue-plasminogen activator (tPA), was first approved by the FDA in 1987. However, tPA can significantly increase the risk of bleeding, so it is used only in a very small percentage of blood clot victims. It's time for a new generation of safer emergency blood clot treatments, and we look forward to working closely with the FDA to develop this truly revolutionary drug candidate."
Fast Track designation is intended to support and expedite the development and approval of drugs that show promise in treating a serious or life-threatening disease. Drugs with Fast Track designation can qualify for accelerated approval and frequent communication with the FDA throughout the development process.
ProCase is a bioengineered enzyme that works by selectively targeting blood clots and safely augmenting the body's own natural antithrombotic, thrombolytic, and cytoprotective mechanisms. The Company has initiated a phase 1 clinical trial for proCase.
Aronora Inc. is a translational biotechnology company engaged in the commercial development of proprietary biologic therapeutics, including recombinant monoclonal antibodies and enzymes. Preclinical and early clinical development of proCase has been partially supported by National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH) under award numbers R44HL095315 and R44HL117589. This content is solely the responsibility of Aronora and does not necessarily represent the official views of the NIH. For more information, please visit www.aronorabio.com.
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