All indications point to approval for cannabis-based therapy
pharmafile | April 17, 2018 | News story | Research and Development, Sales and Marketing | FDA, GW Pharma, biotech, drugs, pharma, pharmaceutical
GW Pharma are inching step by step towards a likely approval with the FDA, after it received a strong recommendation within a briefing document prior to the FDA advisory committee meeting.
GW Pharma’s is seeking indications for two conditions of childhood epilepsy, Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS), for its treatment, Epidiolex. The epilepsy drug is derived from cannabidiol in a purified form and is delivered to patients as a syrup.
The product only contains trace amounts of tetrahydrocannabinol (THC), the psychoactive substance that is the main reason people use the drug recreationally.
The initial analysis of the data on Epidiolex written by Teresa Buracchio, of the FDA, seems to be clearly in favour of approval of the drug: “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.”
This backing comes after the UK- and US-based company were able to post strong results in clinical trials for the indications it’s seeking; in DS, Epidiolex displayed a reduced median number of monthly convulsive seizures from 12.4 to 5.9 while placebo control reduced seizure rate from 14.9 to 14.1.
In LGS, 45% of patients responded to Epidiolex treatment alongside clobazam against 19% using placebo, with monthly and total seizures declining by 62-70% from baseline.
The data and the latest positive noises to come out of the FDA indicate that the drug could be on track to become a blockbuster treatment.
The more significant outcome is that it could open a whole new potential research avenue into researching cannabis for developing potential therapeutics. One of the major milestones that would be passed is the FDA allowing a treatment onto market that is made using the plant, and could see other cannabinoids enter the market space.
First, the next step will be the official convening of the FDA advisory committee meeting on Thursday before a decision is reached prior to 27 June.
Ben Hargreaves
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