GW is developing Epidiolex (cannabidiol) in rare child epilepsies Dravet syndrome, Lennox-Gastaut Syndrome, Tuberous Sclerosis Complex (TSC) and Infantile Spasms.
In a Q3 financial results update, GW’s CEO Justin Gover noted the recent publication of phase 3 trial results in the New England Journal of Medicine.
The UK pharma has begun a rolling submission with the FDA covering Dravet and LGS indications. The company has already submitted preclinical data, and remaining data including clinical trial results are expected to be with the regulator in October.
In Europe, the company expects to file the drug later this year after preparatory meetings with regulators.
Phase 3 trials in TSC and Infantile Spasms are ongoing and the firm is also readying its manufacturing facility for inspection by FDA officials in early 2018.
Preparation is under way in the US for the launch next year if the FDA gives the drug the go-ahead, with Medical and Scientific Liaisons in place.
For the nine months ended June 30, the company lost £90.3 million, compared with £46.7 million in the same period last year, and nine-month revenue was £6.1 million compared with £8.6 million last year.
The financial figures fell short of investors’ expectations, although it is worth noting that if approved in all indications, Epidiolex is expected to generate blockbuster revenues.
Shares in GW dipped slightly after the news, although this could have been due to investors worried about the approvability of cannabis medicines in epilepsy following a phase 2 trial disaster from US biotech, Zynerba.