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 The drug's approval permits its use in patients aged two years and
older with Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS),
rare childhood-onset forms of epilepsy that are among the most
resistant to treatment.
"This approval serves as a reminder that advancing sound development
programs that properly evaluate active ingredients contained in
marijuana can lead to important medical therapies," said Food and
Drug Administration Commissioner Scott Gottlieb.
The drug, Epidiolex, is made up of cannabidiol (CBD), one of the
hundreds of molecules found in the marijuana plant, and contains
less than 0.1 percent of tetrahydrocannabinol (THC), the
psychoactive component that makes people high.
GW Pharma grows its own supply of cannabis in specialized glass
houses in the United Kingdom to ensure uniformity in the genetic
composition of the plants, which are then processed into a liquid
solution of CBD.
Although THC can induce paranoia, anxiety and hallucinations, CBD
has the opposite effect and has been cited by scientists as a
potential treatment for mental health issues.
While supporters of legalizing marijuana say the decision is a step
in the right direction, businesses reliant on the plant must contend
with the federal government's ban on its use.
Based on the potential for abuse, the Drug Enforcement
Administration (DEA) categorizes chemicals into five schedules, with
Schedule 1 substances - like marijuana and heroin - considered the
most deadly and deemed to have no medical benefits.
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.
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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.
Treatments available for both disorders are far from perfect and
some patients resort to buying "self-prescribed" CBD online or from
unregulated vendor sites, Dr. Pavel Klein, founder of the
Mid-Atlantic Epilepsy and Sleep Center, said.
"I hope patients have conversations with their physicians about
whether this product (Epidiolex) provides them with treatment they
have been looking for with other unapproved products," said Douglas
Throckmorton, deputy director of regulatory programs at the FDA's
Center for Drug Evaluation and Research.
(This version of the story has been refiled to correct paragraph 12
to show DEA must make a decision within 90 days of FDA approving a
medicine, instead of there is no time limit.)
(Reporting by Tamara Mathias and Manas Mishra in Bengaluru; Editing
by Shailesh Kuber and Arun Koyyur)
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