US approves first marijuana plant-derived drug
As a result, Epidiolex's launch remains at the discretion of the DEA, which must now evaluate the drug and consider reclassifying it as a substance that has medical properties, so as to allow GW to begin selling it. GW said it expects the reclassification to occur within 90 days.
The company has not yet set a price for the drug and said it would work with insurance providers to ensure the medicine would be covered under health plans.
GW's Nasdaq-listed shares marginally fell in afternoon trading. The stock has run up nearly 50 percent in the past 12 months.
Most patients with LGS and DS require multiple seizure medications and the majority are resistant to currently approved anti-epileptic drugs.
The two epilepsy forms are severe and associated with high rates of mortality. Some LGS patients have to wear helmets to avoid brain injuries from "drop seizures", where muscles suddenly become limp and cause standing patients to collapse.
Epidiolex would also be the first approved therapy for DS, treatments for which are currently limited to a combination of seizure medication and drugs to prevent emergencies.Related Tags
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