ZyVersa Therapeutics (ZVSA) provided regulatory and product support for FDA-authorized Emergency Compassionate Use of Cholesterol Efflux Mediator VAR 200 in a patient with ApoCII amyloidosis. Emergency Compassionate Use, also called Emergency Expanded Access, is a pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational drug for treatment outside of clinical trials when enrollment criteria are not met or there are no comparable or satisfactory alternative therapy options. The patient with ApoCII amyloidosis will receive treatment at the University of Miami Peggy and Harold Katz Family Drug Discovery Center under the care of the Center Director, Dr. Alessia Fornoni, Professor of Medicine, University of Miami Miller School of Medicine, and VAR 200 inventor. VAR 200 treatment and monitoring will follow the protocol of the ongoing DKD clinical trial, VAR200-0301.
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