Revive Therapeutics (TSXV:RVV) submitted an application to the US Food and Drug Administration (FDA) for an orphan drug designation to its cannabidiol (CBD) treatment of hepatic ischemia and reperfusion injury (IRI) during liver transplantation.
As quoted in the press release:
“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.”
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 US 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.