Revive Therapeutics Applies To FDA For Orphan Drug Designation of Cannabidiol For Treatment Of Liver Transplantation

Revive Therapeutics Ltd. announced that it has submitted an application to the U.S. Food and Drug Administration seeking orphan drug designation of cannabidiol for the treatment of hepatic ischemia and reperfusion injury during liver transplantation.

“This orphan drug designation application builds on our pharmaceutical strategy of creating a unique portfolio of cannabinoid therapies targeting rare inflammatory and liver diseases and disorders, and supports our business development activities in partnering with medical-focused licensed producers of cannabis and pharmaceutical companies,” said Fabio Chianelli, President of Revive. “We are dedicated to commercializing novel medical cannabis-based products and therapies as part of our overall ambition in becoming a leading global specialty medical cannabis company, and we are excited in the long-term potential of plant-derived cannabinoid prescription medicines for rare diseases and disorders, which we believe has been validated by the FDA approval of the GW Pharmaceuticals plc EPIDIOLEX. Revive recently announced that the FDA granted orphan drug designation for cannabidiol in the treatment of autoimmune hepatitis, a rare liver disease, and our orphan drug application in liver transplantation is complementary to our liver disease pharmaceutical strategy.”

Liver ischemia-reperfusion injury is a major complication of liver transplantation and is one of the leading causes for post-surgery hepatic dysfunction leading to an increased risk of postoperative morbidity and mortality. According to the United Network for Organ Sharing (“UNOS”) there have been 160,722 liver transplants performed between January 1, 1988 and July 30, 2018. Currently there are 13,773 individuals on the waiting list for a liver transplant. Quickly restoring blood supply of ischemic liver as soon as possible is crucial for avoiding or reducing injury from ischemia, whereas strategies used to attenuate the damage induced by reperfusion, including ischemic preconditioning, ischemic postconditioning, and machine perfusion. These strategies are expensive, sometimes hard to perform in clinical surgeries, and difficult in maintaining liver functions in the case of acute injuries. Revive believes that the immunosuppressant and anti-inflammatory protective effects of CBD may provide a novel, more beneficial strategy to attenuate the damage induced by ischemia and reperfusion during liver 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.