Regulatory

GW Pharma walks away from adcomm with unanimous support for anti-seizure med. An OK shouldn’t take long now

Any small doubts about GW Pharma’s $GWPH chances for a quick OK for their landmark, cannabis-based drug Epidiolex were quickly laid to rest today with a unanimous vote in favor of approval from the expert panel gathered today to offer their advice.

The group voted 13 to 0 in favor of an OK, and FDA officials helpfully told the adcomm members that they were committed to giving this therapy an accelerated decision. And they were backed by an in-house review at the FDA that also endorsed the drug on every major point, recommending an approval.

If that’s not a layup at the FDA, they don’t exist.

Justin Gover, GW Pharma CEO

GW has gathered some impressive efficacy data on their drug, pitched to prevent seizures in children suffering from rare cases of Lennox-Gastaut syndrome and Dravet syndrome. This is shaping up to be the first OK ever for a new class of oral, cannabis-based drugs designed to deliver a therapeutic effect without the high.

Clarivate has pegged 2022 sales at a blockbuster sized $1.2 billion, making this rollout a hugely important event for the UK-based company.

Generally, it’s standard to say here that the panel’s vote is advisory only. The agency doesn’t have to follow through with an approval. But this unanimous decision makes that a moot point.


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