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"The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome have a profound impact on the quality of life of these patients," said Dr. Billy Dunn of the FDA.
"In addition to another important treatment option for Lennox-Gastaut patients, this very first approval of a drug specifically for Dravet patients will bring a significant and necessary improvement in the therapeutic approach to take." care of people with this disease. "
The approval only covers the use of liquid medication for Lennox-Gastaut syndrome and Dravet syndrome. FDA advisers recommended approval in April.
This is not a green light for other marijuana products, Gottlieb said.
"It's an important medical advance," he said. "But it is also important to note that this is not an endorsement of marijuana or any of its components.It is the approval of a specific CBD drug for a specific use. "
It's very different to use pure cannabis in any form whatsoever.
"It is a purified form of CBD and is administered to patients in a reliable, reproducible dosage form to ensure patients receive the desired benefits," he added. Mr. Gottlieb.
Many companies sell cannabis-based treatments, touting them as cancer cures, pain killers, and anti-anxiety medications. The FDA has warned the public not to fall for these unproven allegations.
"The promotion and use of these unapproved products may prevent some patients from accessing appropriate and recognized therapies to treat serious and even life-threatening illnesses," Gottlieb said.
He said the FDA would consider legitimate applications for approval, but said the agency needed solid scientific studies that demonstrate if a product actually works and is safe.
"Such a process ensures that all new therapies of marijuana and its components are safe, effective and manufactured with consistently high quality and above all, that these products have been proven safe and effective for patients," added Gottlieb.
The drug has been shown to reduce seizures and return some children to near-normal function.
Dravet syndrome is a rare genetic disorder that usually occurs in infants, beginning with fever-related seizures and progressing to other, more severe types of seizures.
"Children with Dravet syndrome usually experience poor language development and motor skills, hyperactivity and difficulties related to others," the FDA said.
Lennox-Gastaut syndrome also causes seizures, usually starting in children 3 to 5 years old. "Almost all children with Lennox-Gastaut syndrome develop learning problems and intellectual disabilities," said the FDA.
"Many have also delayed the development of motor skills, such as sitting and crawling.Most people with Lennox-Gastaut syndrome need help with the usual activities of daily living."
Medical marijuana is legal in 29 states, Guam and Puerto Rico. Studies have shown that it can have some benefits in reducing anxiety, by neutralizing certain types of nausea, and that it can relieve some symptoms of glaucoma and multiple sclerosis.
The FDA has approved several marijuana-based products, including the synthetic formulation Marinol, prescribed to treat severe loss of appetite and nausea in conditions such as AIDS. But marijuana products in general are subject to Schedule I restrictions by the Drug Enforcement Administration (DEA) because of the possibility of abuse.
Greenwich Biosciences, the US subsidiary of GW Pharmaceuticals, will sell the product.
"As part of the approval process, Epidiolex must be reprogrammed from its current Schedule I before it can be made available to patients," the company said in a statement. "The rescheduling should take place within 90 days."
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