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US authorities on Monday approved the country's first drug-derived marijuana drug, Epidiolex, which will be used to treat two types of rare but serious childhood epilepsy.
Prepared by the British GW Pharmaceuticals, Epidiolex uses purified cannabidiol, or CBD, which is one of more than 80 active components of the cannabis plant
"This is an important medical breakthrough", said Commissioner Scott Gottlieb of the Food and Drug Administration (FDA). "But it is also important to note that this is not an endorsement of marijuana or all of its components, it is the approval of a specific CBD drug. for a specific use, "he added. 19659002] The drug has been approved to treat Lennox-Gastaut syndromes (LGS) and Dravet, the types of epilepsy cause severe seizures, in patients two years of age or older, says the FDA.
Dravet syndrome is a rare genetic disorder that causes frequent seizures associated with fever, involuntary muscle spasm and permanent life-threatening attacks that require urgent medical attention.
"Like Dravet syndrome, Lennox-Gastaut syndrome also begins in childhood and causes several types of seizures, while most children" For those living with intractable seizures caused by syndromes LGS and Dravet, the Epidiolex represents a true medical breakthrough, "said Philip Gattone, President and CEO of the Foundation for Epilepsy.
Before the drug can be marketed, the FDA must reclassify CBD, which is considered a high-risk drug with no medical value because it is derived from marijuana.
This procedure should be performed within 90 days, according to GW Pharmaceuticals, who will market medicine through its subsidiary Greenwich Biosciences
The European Medicines Agency is currently reviewing the use of Epidiolex to treat LGS syndromes-related seizures and Dravet and his decision is expected next year.
Epidiolex was studied in three randomized trials involving 516 patients with one of the syndromes, to compare the use of the drug with that of a placebo.
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