Revive Therapeutics Ltd. (TSX VENTURE:RVV) (OTCQB:RVVTF) announcedon 6/27/2018 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.”
AIH is a rare autoimmune disease causing inflammation to the liver, which not treated properly, may cause liver fibrosis or cirrhosis, liver failure requiring a liver transplant, and even death. The prevalence of AIH is estimated at 75,000 patients in the U.S. The current standard of care for AIH is the use of steroids alone or steroids combined with azathioprine. It has been noted in medical literature that the current standard of care when used in a certain period of time has caused severe treatment-related side effects in 13%, treatment failure in 9%, incomplete response in 13%, and relapse after drug withdrawal up to 86% of patients with AIH (Source: World J Gastroenterol. 2010 Feb 28; 16(8): 934–947). Given the unwanted outcomes associated with a steroid-based therapy, an alternative steroid-free treatment option such as CBD, with its known safety profile, may provide a potential solution for an improved treatment strategy for those patients unresponsive to, intolerant of, or non-adherent with a steroid-based therapy for AIH.
Revive shares are up 26% as of this writing.
