GW pharmaceuticals PLC, the world's leading pharmaceutical marijuana company, announced that its CBD drug epidyolex has been approved by the Australian Therapeutic commodities authority (TGA) to treat seizures associated with Lennox Gastaut syndrome and Dravet syndrome in patients aged 2 and over.
Epidiolex is an antiepileptic drug based on CBD (cannabinol) developed by GW pharmaceuticals. It is an oral, high-purity liquid preparation of CBD extract.
The approval of the Australian Therapeutic commodities authority (TGA) is the third major breakthrough in the global sales of CBD drug epidyolx after it was approved by the FDA in 2018 and the European Commission (EC) in 2019.
Epidiolex's approval is based on the results of phase III, four randomized controlled trials, which combined data from 714 patients with LGS or Dravet syndrome. LGS or Dravet syndrome is a rare epilepsy with two high incidence rate and mortality.
Many patients with LGS or Dravet syndrome have multiple episodes every day, which brings heavy burden to many families and nursing staff. Although antiepileptic drugs are currently available, these two types of severe epilepsy are still difficult to cure.
Lennox Gastaut syndrome (LGS) is an age-related cryptogenic or symptomatic generalized epilepsy syndrome, which is a type of age-dependent epileptic encephalopathy. It is characterized by early onset age, onset in early childhood, various seizure forms, affected intellectual development, and difficult treatment. It is a serious type of epilepsy.
Dravet syndrome, also known as severe infantile myoclonic epilepsy, is a rare epileptic encephalopathy caused by genetic factors. It has the characteristics of early onset age, various seizure types, high seizure frequency, serious intellectual damage and poor drug treatment effect.
GW will work with chiesi Australia to provide the drug in Australia, and the two companies will work with the drug Welfare Advisory Committee (PBAC) in Australia to ensure that epidiolex can be reimbursed through the drug benefit program (PBS).
Epidiolex is approved by the U.S. Food and Drug Administration (FDA) in August this year to treat seizures associated with "tuberous sclerosis (TSC)" patients aged 1 year and older.
In March, GW pharmaceuticals also submitted a change request to the European Drug Administration (EMA) for approval of epidyolex for the treatment of seizures associated with tuberous sclerosis syndrome (TSC).
Tuberous sclerosis (TSC), also known as Bourneville disease, is an autosomal dominant neurocutaneous syndrome. The incidence rate of childhood onset is about 1/6000, and the ratio of male to female is 2:1. Epilepsy is the main neurological symptom of this disease, with a incidence rate of 70% to 90%.
Epidiolex is the most successful CBD drug in the world at present. It has become the main source of GW pharmaceuticals' revenue in the past two years. In June 2018, the FDA approved epidiolex to go on the market. In November of the same year, GW launched epidiolex on the market. In 2019, epidiolex's annual sales revenue in the United States will reach $311.3 million.