GW Pharma Gets FDA Panel Nod, First Cannabis-based Drug Nearing Approval

Modesto Morganelli
Aprile 20, 2018

Approval would technically limit the drug, called Epidiolex, to patients with hard-to-treat forms of epilepsy.

"This is clearly a breakthrough drug for an bad disease", said panel member Dr. John Mendelson, of the Friends Research Institute in Baltimore.

The drug carries a potential risk of liver damage, but panelists said doctors could monitor patients for any signs.

"The safety concerns could be managed with labeling and monitoring", said Jane Acri, a panel member who works in medication development at the National Institute on Drug Abuse. While the FDA doesn't always follow the advice of the panels, it often does. They described how they have to watch their children constantly, and the horror of their children's seizures, which can be so violent they break bones.

More than two dozen states allow marijuana use for a variety of ailments, but the FDA has not approved it for any medical use. "I would not have been able to do that if I had not tried this medication".

But after receiving Epidiolex, "her seizures went from 40 to 50 a day to only a few or none per week", said Carlin, whose travel was paid for by GW.

Epidiolex comes from a proprietary strain of cannabis grown by GW that has been bred to have high levels of CBD and low levels of THC.

The drug does not contain THC, the psychoactive component in cannabis.

"Having unanimous support [from] the FDA advisory board of evidence-based cannabidiol drugs further motivates and validates the models of companies such as AviCanna and its partners to pursue clinical development of [their] intellectual property", Azadian said.

If approved, the drug would be noteworthy for being the first in a new category of epilepsy treatments, as well as for being the country's first cannabis-derived drug. "If the FDA makes it clear that a cannabis-based pharmaceutical drug has medicinal value, then Congress can no longer claim there is no medicinal quality for cannabis".

This will change eventually and, possibly, sooner rather than later, after the federal Food and Drug Administration on Tuesday gave a positive recommendation for CBD-based drug created to treat children with severe epilepsy.

Shares of GW Pharmaceuticals did not surge much on the news, as the market had already anticipated a decision and traded on speculation, with the stock gaining more than 5.6 percent since Monday.

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