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# FDA Reviewers Give Positive Report on GW Cannabidiol
- URL: https://www.fdaweb.com/fda-reviewers-give-positive-report-on-gw-cannabidiol/
- Published: 2018-04-17T12:00:00.000Z
- Updated: 2026-09-14T23:59:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141241

FDA medical reviewers say three clinical trials conducted by GW Pharma “provide substantial evidence of the effectiveness of CBD (cannabidiol) for the treatment of seizures associated with Lennox-Gestaut syndrome (LGS) and Dravet syndrome (DS) in patients two years of age and older.” The assessment is included in a [briefing document](https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PeripheralandCentralNervousSystemDrugsAdvisoryCommittee/UCM604736.pdf?ref=fdaweb.com) prepared in advance of a 4/19 meeting of the Central Nervous System Drugs Advisory Committee to discuss the company’s NDA for the drug, which is a new molecular entity and structurally unrelated to other drugs approved for treating seizures.

The reviewers also said that the risks associated with CBD treatment appear acceptable, particularly given the findings of clinical efficacy in the two seizure syndromes, which are said to be serious, debilitating, and life-threatening disorders.

“Although the risk of liver injury has the potential to be serious,” the document says, “the observed risk can be appropriately managed with inclusion of relevant language in labeling, education of prescribers regarding the risk of transaminase elevation and need for monitoring of liver enzyme levels, and further characterization of the risk in the post-market setting. Although the review is still ongoing, the risk-benefit profile established by the data in the application appears to support approval of cannabidiol for the treatment of seizures associated with LGS and DS.”