"We are pleased by the advisory committee's unanimous recommendation to approve Epidiolex, which would provide an important treatment option for patients with (Lennox-Gastaut syndrome) and (Dravet syndrome)", Chief Executive Justin Grover said in a prepared statement.
UK-based GW Pharmaceuticals' Epidiolex looks on course for approval in the U.S., after a panel of FDA experts unanimously backed it as a treatment for two rare forms of epilepsy.
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Epidiolex is created to treat Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS), rare childhood-onset forms of epilepsy that are among the most resistant to treatment.
Although the committee's decision is not binding, the regulator usually follows the advice of its advisers, and is set to give a final verdict on Epidiolex before a legal deadline of June 27. The experimental medication from GW Pharmaceuticals PLC is made from Cannabidiol (CBD), a chemical found in the cannabis plant that does not get consumers high. However, the treatment, administered in a syrup form, contains less than 0.1 percent of tetrahydrocannabinol (THC), the substance that makes people high.
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'I think it needs to be approved because everyone is using it across the internet without knowing the safety and no one is watching the interactions with other drugs, ' Dr Conry, from Children's National Health System in Washington, told AP.
In the phase 3 studies, Epidiolex added to other antiepileptic therapies significantly reduced the frequency of seizures in patients with LGS and Dravet syndrome.
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They also warned that it could potentially cause liver injury, but that doctors could manage the risk by monitoring patients' enzyme levels. "It's the first cannabis-based pharmaceutical to be approved by the FDA".