Intercept submits new drug Oberonic acid to FDA for new drug for FIbrosis caused by NASH

recently, Intercept submitted to the U.SFDA(http://for the market of its
new drug,http:// which is used in NASH-induced fibrosisRecently, the European Commission (EC) has approved the Epidiumolex (cannabidiol, cannabidiol, CBD) oral liquid preparation for patients 2 years and older to assist in the treatment of epilepsy associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS), thehttp://
company announcedEpidyolex is the first plant-sourced cannabinoiddrug
in http:// Europe to be approved for the treatment of epilepsy
, paving the way for the drug to be marketed across EuropeIn the United States, the FDA approved cannabidiol oral liquid preparation (product name: Epidiolex) in June 2018 for assisted treatment of LGS and DS-related epilepsy in patients 2 years and olderapproval, making Epidiolex the first high-purity, plant-derived cannabinoid (CBD) prescription drug preparation and the first new anti-epileptic drug (AED)in the U.Smarket, Epidiolex was launched in November 2018Epidyolex's approval is based on the results of four randomized, controlled Phase III clinical studies that were conducted in more than 714 patients with LGS or DSresults showed that When added to other anti-epileptic treatments, Epidyolex significantly reduced the frequency of seizures in PATIENTs with LGS and DSsafety, the most common adverse reactions in patients treated with Epidyolex were drowsiness, loss of appetite, diarrhea, fever, fatigue, and vomitingAbout Epidiolex/Epidyolex
Epidiolex/Epidyolex is an oral, high-purity CBDextract(http://liquid formulation, CBD is a non-psychotic ingredient from cannabis plants that has a variety of pharmacological effects on the nervous systemnumerous studies have shown that CBD has significant anti-epileptic and anticonvulsant activity, with fewer side effects than existing anti-epileptic drugsin the United States, the FDA has granted Epidiolex the status of an orphan drug for treating LGS and DS for rare pediatric diseasesIn addition, the FDA granted Epidiolex fast-track status for the treatment of DSIn Europe, Epidyolex has also been granted the status of orphan drug for the treatment of LGS and DS by THE EMA