GW Pharmaceuticals receives European Commission approval for EPIDYOLEX® (cannabidiol) for the therapy of seizures in individuals with two uncommon, serious types of childhood-onset epilepsy
Cannabidiol oral remedy is the initially plant-derived cannabis-primarily based medicine to be authorized by the European Medicines Agency (EMA)
LONDON and CARLSBAD, Calif., Sept. 23, 2019 (GLOBE NEWSWIRE) — GW Pharmaceuticals plc (Nasdaq: GWPH) (“GW”, “the Company” or “the Group”), planet leader in discovering, building and commercialising cannabinoid prescription medicines, currently announces that the European Commission (EC) has authorized the advertising and marketing authorisation for EPIDYOLEX® for use as adjunctive therapy of seizures related with Lennox‑Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for individuals two years of age and older. The approval paves the way for the launch of the medicine across Europe.
The approval of EPIDYOLEX® marks a important milestone, supplying individuals and their households the initially in a new class of epilepsy medicines and the initially and only EMA-authorized CBD medicine to treat two serious and life-threatening types of childhood-onset epilepsy.
Justin Gover, GW’s Chief Executive Officer
This approval is the culmination of quite a few years of dedication and collaboration in between GW, physicians and the epilepsy neighborhood. We think individuals and physicians deserve access to rigorously tested and evaluated cannabis-primarily based medicines, manufactured to the highest requirements and authorized by medicines regulators, and we are delighted to be the initially to offer you this remedy to the epilepsy neighborhood.
The approval of cannabidiol oral remedy is primarily based on outcomes from 4 randomised, controlled Phase three trials. These research incorporate information from extra than 714 individuals with either LGS or Dravet syndrome, two uncommon types of epilepsy with higher morbidity and mortality prices, which spot a important burden on households and caregivers. Lots of individuals with LGS or Dravet syndrome have various seizures per day, which puts them at ongoing threat of falls and injury. In spite of present anti-epileptic drug therapy, each of these serious types of epilepsy stay very therapy-resistant.1,two,three
“The approval of cannabidiol oral remedy is an essential milestone for individuals and households whose lives are substantially impacted by these uncommon, complicated and life-lengthy types of epilepsy,” mentioned Isabella Brambilla, Chairman, Dravet Syndrome European Federation. “We are quite delighted that individuals will now have access to a a great deal-required, new therapy solution, and 1 routed by means of a rigorous clinical trials programme and licensed by the EMA.”
“LGS and Dravet syndrome are two of the most serious and challenging-to-treat types of childhood-onset epilepsy, with handful of individuals reaching sufficient seizure handle,” mentioned Professor Elinor Ben-Menachem, University of Goteborg, Sahlgren Academy and Hospital in Sweden. “The EMA approval of EPIDYOLEX® will bring hope to individuals and households, with the prospective to greater handle seizures and increase top quality of life.”
When added to other anti-epileptic therapies, EPIDYOLEX® substantially decreased the frequency of seizures in individuals with LGS and Dravet syndrome. The most widespread adverse reactions that occurred in individuals treated with the medicine had been somnolence, decreased appetite, diarrhoea, pyrexia, fatigue and vomiting. GW’s improvement programme represents the only effectively-controlled clinical evaluation of a cannabinoid medication for individuals with LGS and Dravet syndrome.
GW’s cannabidiol oral remedy was authorized by the U.S. Meals and Drug Administration (FDA) in June 2018 below the trade name EPIDIOLEX® for the therapy of seizures related with LGS or Dravet syndrome in individuals two years of age or older.
The EC choice is valid in all 28 nations of the European Union, alongside Norway, Iceland and Liechtenstein.
1. Bourgeois, B. F., Douglass, L. M. and Sankar, R. (2014), Lennox‐Gastaut syndrome: A consensus method to differential diagnosis. Epilepsia, 55: four-9. Doi:10.1111/epi.12567.
two. Arzimanoglou A, French J, Blume WT, et al. Lennox-Gastaut syndrome: a consensus method on diagnosis, assessment, management, and trial methodology. Lancet Neurol. 2009eight(1):82-93.
three. Dravet C. The core Dravet syndrome phenotype. Epilepsia. 201152 Suppl two:three-9.
About GW Pharmaceuticals plc and Greenwich Biosciences, Inc.
Founded in 1998, GW is a UK-primarily based worldwide biopharmaceutical enterprise focused on discovering, building and commercialising novel therapeutics from its proprietary cannabinoid solution platform in a broad variety of illness places. In June 2018 GW, along with its U.S. subsidiary Greenwich Biosciences, received U.S. FDA approval for EPIDIOLEX® (cannabidiol) for the therapy of seizures related with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in individuals two years of age or older. GW created the world’s initially plant-derived cannabinoid prescription medicine, Sativex® (nabiximols), which is authorized for the therapy of spasticity due to various sclerosis in extra than 25 nations about the planet. The Enterprise has a deep pipeline of more cannabinoid solution candidates, which incorporates compounds in Phase 1, two and three trials for epilepsy, autism, glioblastoma and schizophrenia.
About EPIDIOLEX®/EPIDYOLEX® (cannabidiol)
EPIDIOLEX®/EPIDYOLEX® (cannabidiol), the initially prescription, plant-derived cannabis-primarily based medicine authorized by the FDA for use in the U.S., is an oral remedy which consists of very purified cannabidiol (CBD). The medicine is for the therapy of seizures related with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in individuals two years of age or older and is the initially in a new class of anti-epileptic drugs with a novel mechanism of action. EPIDYOLEX® received a good opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Items for Human Use (CHMP) in July 2019 and the European Commission (EC) granted the advertising and marketing authorisation on 23 September 2019 for adjunctive use in conjunction with clobazam. The medicine was granted an Orphan Drug Designation from the EMA for the therapy of seizures related with LGS, Dravet syndrome, and Tuberous Sclerosis Complicated (TSC).
About Dravet syndrome
Dravet syndrome is a serious infantile-onset and very therapy-resistant epileptic encephalopathy regularly related with genetic mutations in the sodium channel gene SCN1A. Onset of Dravet syndrome happens commonly through the initially year of life in previously wholesome and developmentally typical infants. Initial seizures are frequently physique temperature associated, serious, and lengthy-lasting. More than time, individuals with Dravet syndrome frequently create various kinds of seizures, such as tonic-clonic, myoclonic and atypical absences and are prone to bouts of prolonged seizures such as status epilepticus, which can be life threatening. Threat of premature death such as SUDEP (sudden unexpected death in epilepsy) is elevated in individuals with Dravet syndrome. Also, the majority of individuals will create moderate to serious intellectual and improvement disabilities and demand lifelong supervision and care.
About Lennox-Gastaut syndrome (LGS)
The onset of LGS commonly happens in between ages of three to five years and can be triggered by a quantity of situations, such as brain malformations, serious head injuries, central nervous program infections and genetic neuro-degenerative or metabolic situations. In up to 30 % of individuals, no lead to can be discovered. Individuals with LGS generally have various seizure kinds such as drop and convulsive seizures, which regularly lead to falls and injuries, and non-convulsive seizures. Resistance to anti-epileptic drugs (AEDs) is widespread in individuals with LGS. Most individuals with LGS expertise some degree of intellectual impairment, as effectively as developmental delays and aberrant behaviours.
Original Press Release
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