- A review of the FDA advisory committee's briefing document for Thursday's review of GW Pharmaceuticals' (GWPH +10.4%) marketing application seeking approval for its cannabidiol oral solution for the treatment two rare types of epilepsy (LGS or DS) supports a positive vote backing approval. Selected points:
- Efficacy Conclusions (p. 14): Cites the positive results from three randomized placebo-controlled studies and says their design and endpoints "are consistent with other studies that have been used to support drug approvals for epilepsy indications, including LGS." Adding, "The statistically significant and clinically meaningful results from these three studies provide substantial evidence of the effectiveness of CBD (cannabidiol) for the treatment of seizures associated with LGS and DS."
- Safety (p. 24): "in general, the risks associated with cannabidiol appeared to be acceptable." Liver risk should be manageable with appropriate labeling, prescriber education and monitoring of liver enzyme levels.
- Conclusions (p. 24): "Although the review is still ongoing, the risk-benefit profile....appears to support approval...."
- Previously: Ad Com Thursday for GW Pharma's cannabidiol oral solution for types of epilepsy; shares up 11% (April 17)
- Now read: Institutional Top Ideas Series: Broadfin Capital
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