Why Are There So Few FDA-Approved Therapeutics for Wound Healing?

Since the only and the milestone FDA approval of becaplermin gel (Regranex<sup>TM</sup>, 0.01% human recombinant PDGF-BB) as a (diabetic) wound healing therapeutic more than 25 years ago, no new therapeutic (excluding physical therapies, devices, dressings, anti-microbial agents, or othe...

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Main Authors: Mei Chen, Cheng Chang, Brandon Levian, David T. Woodley, Wei Li
Format: Article
Language:English
Published: MDPI AG 2023-10-01
Series:International Journal of Molecular Sciences
Subjects:
Online Access:https://www.mdpi.com/1422-0067/24/20/15109
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author Mei Chen
Cheng Chang
Brandon Levian
David T. Woodley
Wei Li
author_facet Mei Chen
Cheng Chang
Brandon Levian
David T. Woodley
Wei Li
author_sort Mei Chen
collection DOAJ
description Since the only and the milestone FDA approval of becaplermin gel (Regranex<sup>TM</sup>, 0.01% human recombinant PDGF-BB) as a (diabetic) wound healing therapeutic more than 25 years ago, no new therapeutic (excluding physical therapies, devices, dressings, anti-microbial agents, or other preventive treatments) for any type of wound healing has advanced to clinical applications. During the same period of time, the FDA has approved additional 250 new drugs for various human tumors, which were famously described as “wounds that do not heal”. Two similar pathological conditions have experienced such a dramatic difference in therapeutics. More surprisingly, few in the wound healing community seem to be alarmed by this mysterious deficit. As it is often said, “damaging is far easier than re-building”. In contrast to the primary duty of a cancer drug to damage a single molecule of the signaling network, a wound healing drug must be able to re-build the multi-level damages in the wound. No known single molecule alone is capable of repairing multi-cell-type and multi-pathway damages all at once. We argue that the previous single molecule-based strategy for developing wound healing therapeutics is profoundly flawed in theory. The future success of effective wound healing therapeutics requires a fundamental change in the paradigm.
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spelling doaj.art-a46489b49ade46c2a1cf2fe18dcef9152023-11-19T16:41:45ZengMDPI AGInternational Journal of Molecular Sciences1661-65961422-00672023-10-0124201510910.3390/ijms242015109Why Are There So Few FDA-Approved Therapeutics for Wound Healing?Mei Chen0Cheng Chang1Brandon Levian2David T. Woodley3Wei Li4Department of Dermatology, USC-Norris Comprehensive Cancer Center, University of Southern California Keck Medical Center, Los Angeles, CA 90033, USADepartment of Dermatology, USC-Norris Comprehensive Cancer Center, University of Southern California Keck Medical Center, Los Angeles, CA 90033, USADepartment of Dermatology, USC-Norris Comprehensive Cancer Center, University of Southern California Keck Medical Center, Los Angeles, CA 90033, USADepartment of Dermatology, USC-Norris Comprehensive Cancer Center, University of Southern California Keck Medical Center, Los Angeles, CA 90033, USADepartment of Dermatology, USC-Norris Comprehensive Cancer Center, University of Southern California Keck Medical Center, Los Angeles, CA 90033, USASince the only and the milestone FDA approval of becaplermin gel (Regranex<sup>TM</sup>, 0.01% human recombinant PDGF-BB) as a (diabetic) wound healing therapeutic more than 25 years ago, no new therapeutic (excluding physical therapies, devices, dressings, anti-microbial agents, or other preventive treatments) for any type of wound healing has advanced to clinical applications. During the same period of time, the FDA has approved additional 250 new drugs for various human tumors, which were famously described as “wounds that do not heal”. Two similar pathological conditions have experienced such a dramatic difference in therapeutics. More surprisingly, few in the wound healing community seem to be alarmed by this mysterious deficit. As it is often said, “damaging is far easier than re-building”. In contrast to the primary duty of a cancer drug to damage a single molecule of the signaling network, a wound healing drug must be able to re-build the multi-level damages in the wound. No known single molecule alone is capable of repairing multi-cell-type and multi-pathway damages all at once. We argue that the previous single molecule-based strategy for developing wound healing therapeutics is profoundly flawed in theory. The future success of effective wound healing therapeutics requires a fundamental change in the paradigm.https://www.mdpi.com/1422-0067/24/20/15109wound healingtherapeuticsbuilder vs damager
spellingShingle Mei Chen
Cheng Chang
Brandon Levian
David T. Woodley
Wei Li
Why Are There So Few FDA-Approved Therapeutics for Wound Healing?
International Journal of Molecular Sciences
wound healing
therapeutics
builder vs damager
title Why Are There So Few FDA-Approved Therapeutics for Wound Healing?
title_full Why Are There So Few FDA-Approved Therapeutics for Wound Healing?
title_fullStr Why Are There So Few FDA-Approved Therapeutics for Wound Healing?
title_full_unstemmed Why Are There So Few FDA-Approved Therapeutics for Wound Healing?
title_short Why Are There So Few FDA-Approved Therapeutics for Wound Healing?
title_sort why are there so few fda approved therapeutics for wound healing
topic wound healing
therapeutics
builder vs damager
url https://www.mdpi.com/1422-0067/24/20/15109
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