Cannabinoid-Based Tx Gets Orphan Drug Designation for Autoimmune Hepatitis
Revive Therapeutics announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation for cannabidiol in the treatment of autoimmune hepatitis (AIH), a rare disease that causes inflammation of the liver. Cannabidiol is a non-psychoactive component of marijuana that does not cause intoxication or euphoria that comes from tetrahydrocannabinol.
Currently, the standard of care for AIH includes steroid monotherapy or combination treatment with azathioprine. Treatment with a steroid-free option, like cannabidiol, may be a potential alternative for patients who are unresponsive to, or intolerant of steroid-based therapies.
"We are very pleased to receive orphan drug designation for [cannabidiol] in the treatment of AIH from the FDA," said Fabio Chianelli, President of Revive. "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 more information visit ReviveThera.com.