FDA advisory committee sets GW Pharma up for approval
pharmafile | April 20, 2018 | News story | Medical Communications, Sales and Marketing | Epidiolex, GW Pharma, biotech, drugs, pharma, pharmaceutical
After the FDA advisory committee unanimously recommended GW Pharma’s Epidiolex for approval, the chances of it not receiving the nod are now slim to none.
All the data released by GW Pharma had pointed towards a strong case for approval, with a number of Phase 3 trials having been conducted to prove the drug’s efficacy in treating Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS).
However, there has always remained one question mark – would the FDA approve a treatment that is derived from cannabis?
The active ingredient in the drug is purified cannabidiol that is delivered in the form of a syrup and, to develop the treatment, the UK based company has to grow vast amounts of plant to provide the raw materials for its treatment.
The treatment only contains trace amounts of tetrahydrocannabinol (THC) – the primary reason many people use the drug recreationally.
US federal law currently states that there is no medicinal value to the cannabis plant, which may come under fire if a treatment that is developed through the use of the plant is approved as having therapeutic benefits.
The advisory committee certainly seemed to think it had benefits, with a vote of 13-0 in favour of approving and the information provided to the committee also being strongly in favour of the drug.
Initial analysis of the data on Epidiolex written by Teresa Buracchio, of the FDA, was 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.”
The clinical trial results speak for themselves, 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 FDA will make a decision before 27 June so a definite answer will be had in the coming months, although anything other than an approval would represent a major shock.
Ben Hargreaves
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