Cannabidiol Receives Orphan Drug Designation for Autoimmune Hepatitis

According to a story from, the company Revive Therapeutics, which is dedicated to the development of treatments derived from cannabis and cannabinoids, recently announced that the FDA has decided to grant Orphan Drug designation for cannabidiol (CBD) for the treatment of the rare liver disease autoimmune hepatitis.

CBD in Medicine

Currently, CBD is the primary substance derived from the cannabis plant to be involved in drug development and research. CBD has recently gained approval for treating severe epilepsy caused by Dravet syndrome and Lennox-Gastaut syndrome. It is also an active ingredient in Sativex, an oral spray containing CBD and THC (the psychoactive component in cannabis) that is approved in Canada for treating pain associated with multiple sclerosis. CBD has anti-inflammatory and immune system regulating properties.

About Autoimmune Hepatitis

Autoimmune hepatitis is a long term disease of the liver that can present similar to regular hepatitis, but without any indication of infection. In autoimmune hepatitis, the body’s immune system attacks liver cells, causing symptoms such as inflammation, fatigue, weight loss, joint pain, jaundice, abdominal pain, nausea, and fever. In some cases, symptoms may initially not appear even though liver function is being affected and there are clear signs of long term liver damage. What causes this autoimmune hepatitis is still not clearly understood.

Treatment typically involves immune suppressing glucosteroids such as prednisone. This can achieve remission in up to 80 percent of cases, but most patients experience relapse. Another problem is that patients tend to have lowered life expectancy, even if they respond well to treatment. Clearly, new therapeutic approaches are needed to improve outcomes for patients. To learn more about autoimmune hepatitis, click here.

The Benefits of Orphan Drug Designation

The granting of Orphan Drug designation provides renewed encouragement to the development team at Revive, and also means that they will receive several benefits that accompany the designation. These benefits include a waiving of certain fees, tax credits, fast tracking of some regulatory processes, and a period of seven year market exclusivity if the product obtains approval from the FDA.

Orphan Drug designation is reserved for treatments that display the potential to provide substantial advantages over currently available treatments and are geared towards illnesses that are considered rare. A rare disease in the US is legally defined as any illness that affects less than 200,000 patients on a yearly basis.


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