GW Pharmaceuticals plc (Nasdaq: GWPH) (“GW”, “the Company” or “the
Group”), world leader in discovering, developing and
commercialising cannabinoid prescription medicines, today announces
that the European Commission (EC) has approved the marketing
authorisation for EPIDYOLEX® for use as adjunctive therapy of
seizures associated with Lennox‑Gastaut syndrome (LGS) or Dravet
syndrome, in conjunction with clobazam, for patients 2 years of age
and older. The approval paves the way for the launch of the
medicine across Europe.
“The approval of EPIDYOLEX®
marks a significant milestone, offering patients and their families
the first in a new class of epilepsy medicines and the first and
only EMA-approved CBD medicine to treat two severe and
life-threatening forms of childhood-onset epilepsy,” said Justin
Gover, GW’s Chief Executive Officer. “This approval is the
culmination of many years of dedication and collaboration between
GW, physicians and the epilepsy community. We believe patients and
physicians deserve access to rigorously tested and evaluated
cannabis-based medicines, manufactured to the highest standards and
approved by medicines regulators, and we are delighted to be the
first to offer this solution to the epilepsy community.”
The approval of cannabidiol oral solution is
based on results from four randomised, controlled Phase 3 trials.
These studies incorporate data from more than 714 patients with
either LGS or Dravet syndrome, two rare forms of epilepsy with high
morbidity and mortality rates, which place a significant burden on
families and caregivers. Many patients with LGS or Dravet syndrome
have multiple seizures per day, which puts them at ongoing risk of
falls and injury. Despite current anti-epileptic drug treatment,
both of these severe forms of epilepsy remain highly
treatment-resistant.1,2,3
“The approval of cannabidiol oral solution is an
important milestone for patients and families whose lives are
significantly impacted by these rare, complex and life-long forms
of epilepsy,” said Isabella Brambilla, Chairman, Dravet Syndrome
European Federation. “We are very happy that patients will now have
access to a much-needed, new treatment option, and one routed
through a rigorous clinical trials programme and licensed by the
EMA.”
“LGS and Dravet syndrome are two of the most
severe and difficult-to-treat forms of childhood-onset epilepsy,
with few patients achieving adequate seizure control,” said
Professor Elinor Ben-Menachem, University of Goteborg, Sahlgren
Academy and Hospital in Sweden. “The EMA approval of EPIDYOLEX®
will bring hope to patients and families, with the potential to
better control seizures and improve quality of life.”
When added to other anti-epileptic therapies,
EPIDYOLEX® significantly reduced the frequency of seizures in
patients with LGS and Dravet syndrome. The most common adverse
reactions that occurred in patients treated with the medicine were
somnolence, decreased appetite, diarrhoea, pyrexia, fatigue and
vomiting. GW’s development programme represents the only
well-controlled clinical evaluation of a cannabinoid medication for
patients with LGS and Dravet syndrome.
GW’s cannabidiol oral solution was approved by
the U.S. Food and Drug Administration (FDA) in June 2018 under the
trade name EPIDIOLEX® for the treatment of seizures associated with
LGS or Dravet syndrome in patients two years of age or older.
The EC decision is valid in all 28 countries 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 approach to
differential diagnosis. Epilepsia, 55: 4-9.
Doi:10.1111/epi.12567.2. Arzimanoglou A, French J, Blume WT, et al.
Lennox-Gastaut syndrome: a consensus approach on diagnosis,
assessment, management, and trial methodology. Lancet Neurol.
2009;8(1):82-93.3. Dravet C. The core Dravet syndrome phenotype.
Epilepsia. 2011;52 Suppl 2:3-9.
ADDITIONAL INFORMATION
About GW Pharmaceuticals plc and
Greenwich Biosciences, Inc.Founded in 1998, GW is a
UK-based global biopharmaceutical company focused on discovering,
developing and commercialising novel therapeutics from its
proprietary cannabinoid product platform in a broad range of
disease areas. In June 2018 GW, along with its U.S. subsidiary
Greenwich Biosciences, received U.S. FDA approval for EPIDIOLEX®
(cannabidiol) for the treatment of seizures associated with
Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two
years of age or older. GW developed the world’s first plant-derived
cannabinoid prescription medicine, Sativex® (nabiximols), which is
approved for the treatment of spasticity due to multiple sclerosis
in more than 25 countries around the world. The Company has a deep
pipeline of additional cannabinoid product candidates, which
includes compounds in Phase 1, 2 and 3 trials for epilepsy, autism,
glioblastoma and schizophrenia.
About
EPIDIOLEX®/EPIDYOLEX®
(cannabidiol)EPIDIOLEX®/EPIDYOLEX®
(cannabidiol), the first prescription, plant-derived cannabis-based
medicine approved by the FDA for use in the U.S., is an oral
solution which contains highly purified cannabidiol (CBD). The
medicine is for the treatment of seizures associated with
Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two
years of age or older and is the first in a new class of
anti-epileptic medications with a novel mechanism of action.
EPIDYOLEX® received a positive opinion from the European Medicines
Agency’s (EMA) Committee for Medicinal Products for Human Use
(CHMP) in July 2019 and the European Commission (EC) granted the
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 treatment of seizures associated
with LGS, Dravet syndrome, and Tuberous Sclerosis Complex
(TSC).
About Dravet syndrome Dravet
syndrome is a severe infantile-onset and highly treatment-resistant
epileptic encephalopathy frequently associated with genetic
mutations in the sodium channel gene SCN1A. Onset of Dravet
syndrome occurs typically during the first year of life in
previously healthy and developmentally normal infants. Initial
seizures are often body temperature related, severe, and
long-lasting. Over time, patients with Dravet syndrome often
develop multiple types of seizures, including tonic-clonic,
myoclonic and atypical absences and are prone to bouts of prolonged
seizures including status epilepticus, which can be life
threatening. Risk of premature death including SUDEP (sudden
unexpected death in epilepsy) is elevated in patients with Dravet
syndrome. Additionally, the majority of patients will develop
moderate to severe intellectual and development disabilities and
require lifelong supervision and care.
About Lennox-Gastaut syndrome
(LGS) The onset of LGS typically occurs between ages of 3
to 5 years and can be caused by a number of conditions, including
brain malformations, severe head injuries, central nervous system
infections and genetic neuro-degenerative or metabolic conditions.
In up to 30 percent of patients, no cause can be found. Patients
with LGS commonly have multiple seizure types including drop and
convulsive seizures, which frequently lead to falls and injuries,
and non-convulsive seizures. Resistance to anti-epileptic drugs
(AEDs) is common in patients with LGS. Most patients with LGS
experience some degree of intellectual impairment, as well as
developmental delays and aberrant behaviours.
Forward-looking statementsThis
news release contains forward-looking statements that reflect GW's
current expectations regarding future events, including statements
regarding financial performance, the timing of clinical trials, the
timing and outcomes of regulatory or intellectual property
decisions, the relevance of GW products commercially available and
in development, the clinical benefits of EPIDIOLEX®/EPIDYOLEX®
(cannabidiol) oral solution and Sativex® (nabiximols), and the
safety profile and commercial potential of both medicines.
Forward-looking statements involve risks and uncertainties. Actual
events could differ materially from those projected herein and
depend on a number of factors, including (inter alia), the success
of GW’s research strategies, the applicability of the discoveries
made therein, the successful and timely completion and
uncertainties related to the regulatory process, and the acceptance
of EPIDIOLEX®/EPIDYOLEX®, Sativex® and other products by consumer
and medical professionals. A further list and description of risks
and uncertainties associated with an investment in GW can be found
in GW’s filings with the U.S. Securities and Exchange Commission.
Existing and prospective investors are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date hereof. GW undertakes no obligation to update or revise
the information contained in this press release, whether as a
result of new information, future events or circumstances or
otherwise.
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