Revive Therapeutics (TSXV:RVV; OTCQB:RVVTF)Â announced that it has submitted an application to the US Food and Drug Administration (FDA) seeking orphan drug designation of cannabidiol (CBD) for the treatment of autoimmune hepatitis (AIH).
As quoted in the press release:
“This orphan drug designation application is an important first step in the commercial development process of cannabidiol for the potential treatment of autoimmune hepatitis,” said Craig Leon, Chief Executive Officer of Revive. “We are focused on advancing the research of novel therapies that target the endocannabinoid system, such as the CB1 and CB2 endocannabinoid receptors, and further strengthen our product pipeline with potentially safer and effective treatments for various liver diseases.”
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.