As reported by STAT, the approval for Epidiolex (cannabidiol) was announced on Monday. The drug was approved for use in two rare but crippling forms of epilepsy.
Made by GW Pharmaceuticals, the CBD-based drug includes a component of the marijuana plant that does not get users “high.” Given to patients as an oil, it was shown to reduce the number of seizures by about 40 percent in clinical trials for those diagnosed with Dravet or Lennox-Gastaut syndromes.
“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,” FDA Commissioner Scott Gottlieb said in a statement. “And, the FDA is committed to this kind of careful scientific research and drug development.”
STAT reported that the FDA’s decision to approve Epidiolex was anticipated. Agency officials had previously said they supported the approval, while an advisory panel had already unanimously recommended it be offered as a treatment to appropriate patients.
Some health experts expressed concerns that the drug may have a detrimental effect on the liver. But others said the potential risk could be addressed by physicians and other primary care providers when they monitor patients during treatment with Epidiolex
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