FDA Grants Orphan Drug Designation for Another Cannabis-derived Drug
Very high magnification micrograph of autoimmune hepatitis. H&E stain. Credit: Nephron on WikiMedia Commons
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Revive Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for cannabidiol (CBD) in the treatment of autoimmune hepatitis (AIH) to Revive.
"We are very pleased to receive orphan drug designation for CBD in the treatment of AIH from the FDA as it allows us to confidently advance our research and development plans with our strategic collaboration partner WeedMD Inc.," said Fabio Chianelli, President of Revive. "This milestone builds on Revive’s pharmaceutical strategy in developing novel cannabinoid therapies targeting both broad and rare inflammatory and liver diseases and it supports our near-term product and business development strategy in commercializing novel cannabis-based therapies and potential partnering opportunities with licensed producers of cannabis and pharmaceutical companies. We are excited about the long-term potential of plant-derived cannabinoid prescription medicines, which we believe has been validated by the FDA approval of the GW Pharmaceuticals plc EPIDIOLEX® (cannabidiol) oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years of age or older.”
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.