Milepost! Epidilex, the first cannabinoid drug, has been approved by the US FDA for the treatment of two rare pediatric epilepsy

June 25, 2018 / BIOON / -- GW Pharma, a British pharmaceutical company, is a global leader in the research and development of plant-based cannabinoid treatment products, committed to the discovery, development and commercialization of new therapeutic drugs from cannabis Recently, the company announced that the U.S FDA has approved the oral liquid preparation of epidilex (cannabidiol) for the treatment of epilepsy related to Lennox Gastaut syndrome (LGS) and Dravet syndrome (DS) in patients aged 2 and over It is worth mentioning that this approval makes epidiolex the first high-purity, plant-derived cannabis diol (CBD) prescription drug preparation, as well as the first new antiepileptic drug (AED) GW chief executive Justin gover said the approval of epidiolex marks a historic milestone and will provide patients and their families with the first and only FDA approved CBD drug for the treatment of two serious childhood epilepsy GW expects to bring epidiolex to the US market in the next three months The industry is also very optimistic about the business prospects of epidilex At the beginning of this year, corellion released a report predicting that epidilex's sales will reach US $1.2 billion in 2022 Epidiolex is an oral, high-purity CBD extract liquid preparation, CBD is a non spiritual component from cannabis plant, which has a variety of pharmacological effects on the nervous system A large number of studies have shown that CBD has obvious antiepileptic and anticonvulsant activities, with fewer side effects than existing antiepileptic drugs In the United States, FDA has granted epidilex orphan status in the treatment of LGS and DS In addition, FDA has granted epidiolex a fast track status in the treatment of DS In Europe, epidiolex has also been granted orphan status by EMA to treat LGS and DS Epidiolex adjuvant therapy for LGS and DS related epilepsy was approved based on data from three phase III Safety and efficacy studies, each of which reached the primary end point In these studies, epidiolex was generally well tolerated The Epidiolex NDA includes safety data for about 1500 patients, as well as data for about 400 patients treated continuously for more than 1 year In addition to key safety and efficacy data, NDA includes a comprehensive set of clinical pharmacology, preclinical and toxicology data Lennox Gastaut syndrome (LGS) is an age-related cryptogenic or symptomatic generalized epilepsy syndrome, a type of age-dependent epilepsy encephalopathy It is characterized by early onset age, early childhood onset, various attack forms, intellectual development affected, and difficult treatment It is a serious type of epilepsy Dravet syndrome (DS), also known as infantile severe myoclonic epilepsy, is a rare progressive epileptic encephalopathy mainly caused by genetic factors It has the characteristics of early onset age, various types of seizures, high frequency of seizures, serious intellectual damage, poor efficacy of drug treatment and so on The prognosis of this disease is poor, and almost all children have cognitive impairment Original source: GW pharmaceuticals PLC and its U.S subsidiary Greenwich Biosciences announcement FDA approval of epidiolex ® (Canada) oral solution – the first plant derived Canada prescription medicine