Milepost! Epidyolex, the first plant-based cannabinoid drug, has been approved by the European Union for the treatment of two rare pediatric epilepsy

September 24, 2019 / 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 European Commission (EC) has approved the oral liquid preparation of epidyolex (cannabidiol, cannabis glycol, CBD) for the treatment of epilepsy related to Lennox Gastaut syndrome (LGS) and Dravet syndrome (DS) in patients aged 2 and over Epidyolex is the first plant-based cannabinoid drug approved in Europe for treatment of epilepsy, which paves the way for the drug's launch across Europe In the United States, FDA approved cannabidiol oral liquid preparation (trade name: epidiolex) in June 2018 for adjuvant treatment of LGS and DS related epilepsy in patients aged 2 and over It is worth mentioning that this approval makes epidiolex the first prescription drug preparation with high purity and plant source of cannabis diol (CBD), as well as the first new antiepileptic drug (AED) In the US market, epidiolex was launched in November 2018 The industry is also very optimistic about the business prospects of epidilex / epidyolex According to a report released last year by corellion, epidiolex's sales in 2022 are expected to reach $1.2 billion The approval of epidyolex is based on the results of four randomized, controlled phase III clinical studies involving more than 714 LGS or DS patients The results showed that epidyolex significantly reduced seizure frequency in LGS and DS patients when added to other antiepileptic therapies In terms of safety, the most common adverse reactions in patients treated with epidyolex are drowsiness, anorexia, diarrhea, fever, fatigue and vomiting GW's development represents the only well controlled clinical evaluation program to evaluate a cannabinoid drug for LGS and DS patients "The approval of epidyolex marks a major milestone in providing patients and their families with the first new class of antiepileptic drugs," said Justin gover, GW's chief executive Epidyolex is the first new AED approved in Europe and the first and only cannabinoid drug to treat two kinds of severe and life-threatening childhood epilepsy, which is a historic breakthrough " Epidiolex / epidyolex is a kind of oral liquid preparation of CBD extract with high purity CBD is a kind of non spiritual component from cannabis plant, which has many pharmacological effects on 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, epidyolex has also been granted orphan status by EMA to treat LGS and DS 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 receives European Commission approval for epidyolex ® (Canada) for the treatment of diseases in patients with two rares, severe forms of childhood onset epilepsy