FDA

GW Pharma’s cannabis-based drug appears poised for a groundbreaking FDA approval as internal review offers a clear thumbs up

GW Pharmaceuticals’ $GWPH lead drug picked up a clear endorsement from regulators at the FDA this morning.

In the agency’s internal review of GW’s Epidiolex ahead of an upcoming expert panel review, regulators concluded that the biotech’s data backed both the efficacy of the cannabinoid drug as well as an acceptable safety profile — a clear indication that the drug appears on a straight path toward a landmark approval for Lennox-Gastaut syndrome and Dravet syndrome.

The biotech’s shares surged 11% as investors scanned the agency’s opinions.

Teresa Buracchio was the team leader on the review at CDER, and she didn’t hedge her opinion in the review.

The statistically significant and clinically meaningful results from these three studies provide substantial evidence of the effectiveness of CBD for the treatment of seizures associated with LGS and DS.

Justin Gover, GW Pharma CEO

Regulators are also ready to give GW’s drug a pass on the safety profile. The main problem linked to the drug was liver toxicity, which is no light matter at the FDA. But the reviewer notes that there’s nothing about liver damage that physicians couldn’t manage appropriately, coming down squarely in the drug’s favor.

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.

The London-based biotech has excited investors with data from a series of late-stage studies on Epidiolex, noting in one case that the drug reducing convulsions in children with treatment-resistant Dravet syndrome by a median average of 39% compared to only 13% in the placebo arm. That data helped inspire blockbuster-sized peak sales estimates for this drug.

Those numbers won’t be coming down any in the wake of this review. The PDUFA date is June 27 and GW is making plans for an immediate rollout in the second half of this year.

 


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Molecular Templates Austin, TX
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Molecular Templates Austin, TX
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Koneksa Health New York, NY

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