GW cannabis-derived epilepsy drug gets positive FDA staff review

Cannabis-derived medicine from GW Pharmaceuticals for severe childhood epilepsy has got a positive review from the US FDA staff, on Tuesday, for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS) in patients 2 years of age and older, thereby enhancing possibilities for its approval in near future.

Both LGS and DS are rare, severe, refractory epilepsy syndromes with onset in early childhood. The syndromes are categorized as developmental and epileptic encephalopathies, in which the epileptic activity is thought to contribute to developmental delay and behavioral abnormalities beyond the pathology of the underlying disease. The syndromes are characterized by multiple seizure types that are generally refractory to many of the drugs typically used for the treatment of seizures. Both syndromes are associated with higher rates of mortality than in the general epilepsy population, primarily due to status epilepticus and sudden unexpected death in epilepsy patients (SUDEP).

Epidiolex, GW’s lead cannabinoid product candidate is a pharmaceutical formulation of purified cannabidiol (CBD), which is in development for the treatment of several rare childhood-onset epilepsy disorders. GW has submitted a New Drug Application with the FDA for Epidiolex as adjunctive treatment for seizures associated with LGS and Dravet syndrome, which has been assigned a goal date of 27 June 2018 and, if approved, the medicine is expected to be available by prescription in the second half of 2018. GW has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with an expected decision date in early 2019. To date, GW has received Orphan Drug Designation from the FDA for Epidiolex for the treatment of Dravet syndrome, LGS, TSC and IS. Additionally, GW has received Fast Track Designation from the FDA for the treatment of Dravet syndrome and conditional grant of rare pediatric disease designation by FDA. The Company has also received Orphan Designation from the European Medicines Agency, or EMA, for Epidiolex for the treatment of LGS, Dravet syndrome, West syndrome and TSC.

As per the briefing document published on FDA website, Clinically meaningful and statistically significant reductions in seizure frequency were demonstrated in three adequate and well-controlled trials in LGS and DS. The results from these three studies provide substantial evidence of the effectiveness of CBD for the treatment of seizures associated with LGS and DS. In general, the risks associated with CBD treatment appear acceptable, particularly given the findings of clinical efficacy in LGS and DS, which are serious, debilitating, and life-threatening disorders. Although the risk of liver injury has the potential to be serious, the observed risk can be appropriately managed with inclusion of relevant language in labeling, education of prescribers regarding the risk of transaminase elevation and need for monitoring of liver enzyme levels, and further characterization of the risk in the post-market setting. 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.

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News Source: FDA website

Image source: http://www.justscience.in/articles/people-get-epilepsy-can-best-treated/2017/12/22