Revive Therapeutics Granted FDA Orphan Drug Designation

Share the love

According to a recent announcement made by Revive Therapeutics, the company has been granted an FDA Orphan Drug Designation for the use of cannabidiol (“CBD”) in preventing ischemia and reperfusion injury (“IRI”) — both of which can result from solid organ transplantation.

Under the Orphan Drug Act of 1983, the FDA provides incentives for companies developing treatments that are expected to provide significant therapeutic advantage over existing treatments, and that target rare medical conditions affecting fewer than 200,000 U.S. patients per year. Incentives include seven-year market exclusivity, tax credits on U.S. clinical trials, fast-tracking of regulatory proceedings, and exemption from certain fees, such as waiver of filing fees under the Prescription Drug User Fee Act (PDUFA) and orphan drug grants.

Leave a Reply