Anges Co., Ltd. Announcement of gene therapy product “Collategene” designated as breakthrough therapy (gro undbreaking new drug) by the U.S. FDA

Anges Co., Ltd.
Announcement of gene therapy product “Collategene” designated as breakthrough therapy (groundbreaking new drug) by the U.S. FDA ……
AnGes Co., Ltd. is pleased to announce that the gene therapy product “Collategene”, which is being developed in the United States as a treatment for peripheral artery disease, has been designated as Breakthrough Therapy designation by the U.S. Food and Drug
Administration (FDA). Masu.
Peripheral artery disease affects 200 million people worldwide and is a complex disease that can lead to extremely serious complications such as ulcers, infections, and ultimately lower limb amputation (1). According to a report by Professor David Armstrong of the University of Southern California School of Medicine and colleagues, when compared to cancer, the 5-year mortality rate after major lower limb amputation (proximal to the ankle) is 57%, second only to lung cancer at 80% (2 ,3). By starting treatment with Collategene at a relatively early stage for peripheral artery disease with ischemic ulcers, which have a poor prognosis and do not require revascularization, treatment of the ulcer and extension of time until lower extremity amputation can be achieved. It is expected that this will lead to improved quality of life for future patients. Globally consensus treatment guidelines also recommend early treatment (4).
The Breakthrough Therapy designation was designed by the FDA to expedite the development and review of drugs for the treatment of serious and life-threatening diseases. This means that the results of clinical trials have shown that the treatment has the potential to show significant improvements over existing treatments.
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(1)Allison MA, et al. Health Disparities in Peripheral Artery Disease: A Scientific Statement from the American Heart Association.
Circulation. 2023 Jul 18;148(3):286-296.
(2)Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375.
(3)Armstrong DG, et al. Five year mortality and direct costs of care for people with diabetic foot complications are comparable to cancer. Journal of foot and ankle research. 2020;13(1):1 -4
(4) Michael S. Conte, et al. Global vascular guidelines on the management of chronic limb-threatening ischemia. Journal of Vascular Surgery. 2019;Volume 69, Number 6S