An experimental cell therapy developed at the University of Wisconsin Health in Madison has received the FDA’s fast-track designation.
The treatment, developed through a partnership between UW Health and the UW School of Medicine and Public Health, is designed to treat xerostomia, according to a May 7 news release.
Xerostomia, or dry mouth, is a common side effect of radiation for head and neck cancer. The cell therapy is currently in a phase 1 trial at the health system’s Carbone Clinical Center in Madison.
A UW Health spokesperson told Becker’s this is the first FDA fast-track designation since 2012 given to an organization that is not a private commercial drug developer.
The fast-track designation expedites the agency’s review of a drug candidate that treats a serious condition and meets an unmet clinical need.
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