GW Pharmaceuticals Announces Acceptance of NDA Filing for Epidiolex® (cannabidiol) in the treatment of Lennox-Gastaut syndro...
December 28 2017 - 7:00AM
GW Pharmaceuticals plc (Nasdaq:GWPH) (“GW” or “the Company”), a
biopharmaceutical company focused on discovering, developing and
commercializing novel therapeutics from its proprietary cannabinoid
product platform, today announced that the U.S. Food and Drug
Administration (FDA) has accepted for filing with Priority Review
its recently submitted New Drug Application (NDA) for
Epidiolex® (cannabidiol or CBD), an investigational treatment
for seizures associated with Lennox-Gastaut syndrome (LGS) and
Dravet syndrome, two rare and difficult to treat conditions of
childhood-onset epilepsy. The PDUFA (Prescription Drug User Fee
Act) goal date for completion of the FDA review of the Epidiolex
NDA is June 27, 2018.
Priority Review status is designated for drugs
that may offer major advances in treatment or provide a treatment
where no adequate therapies exist. The granting of Priority
Review for the Epidiolex NDA accelerates the timing of the FDA
review of the application compared to a standard review.
In its acceptance letter, the FDA has stated
that it is currently planning to hold an advisory committee meeting
to discuss this application.
“We are pleased with the FDA’s acceptance of our
NDA filing with Priority Review, an action that underscores the
unmet need in the LGS and Dravet syndrome populations,” said Justin
Gover, GW’s Chief Executive Officer. “We look forward to working
with the FDA during the review process to support the case for
approval of Epidiolex so as to provide a much needed new treatment
option for patients that suffer from these highly
treatment-resistant conditions of childhood-onset epilepsy.”
About Lennox-Gastaut
Syndrome
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
children with LGS experience some degree of intellectual
impairment, as well as developmental delays and aberrant
behaviors.
About Dravet Syndrome
Dravet syndrome is a severe infantile-onset and
highly treatment-resistant epileptic encephalopathy frequently
associated with genetic mutations in the SCN1A sodium channels.
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 will develop moderate to
severe intellectual and development disabilities and require
lifelong supervision and care. There are currently
no FDA-approved treatments and nearly all patients continue to
experience seizures and other medical needs throughout their
lifetime.
About
Epidiolex®
(cannabidiol)
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 with an expected
approval and launch in 2018. 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. GW is currently evaluating
additional clinical development programs in other orphan seizure
disorders including Phase 3 trials in Tuberous Sclerosis Complex
and Infantile Spasms.
About GW Pharmaceuticals plc and
Greenwich Biosciences
Founded in 1998, GW is a biopharmaceutical
company focused on discovering, developing and commercializing
novel therapeutics from its proprietary cannabinoid product
platform in a broad range of disease areas. GW, along with its U.S.
subsidiary Greenwich Biosciences, is advancing an orphan drug
program in the field of childhood epilepsy with a focus on
Epidiolex (cannabidiol), for which GW has submitted an NDA to the
FDA for the adjunctive treatment of LGS and Dravet syndrome. The
Company continues to evaluate Epidiolex in additional epilepsy
conditions and currently has ongoing clinical trials in Tuberous
Sclerosis Complex and Infantile Spasms. GW commercialized the
world’s first plant-derived cannabinoid prescription drug, Sativex®
(nabiximols), which is approved for the treatment of spasticity due
to multiple sclerosis in numerous countries outside the United
States. The Company has a deep pipeline of additional cannabinoid
product candidates which includes compounds in Phase 1 and 2 trials
for gliobastoma, schizophrenia and epilepsy. For further
information, please visit www.gwpharm.com.
Forward-looking statements
This 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® (cannabidiol) and the safety profile and commercial
potential of Epidiolex. 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 Sativex, Epidiolex 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, including the most recent Form
20-F filed on 4 December 2017. 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.
Enquiries:
GW Pharmaceuticals plc |
|
Stephen Schultz, VP Investor Relations (U.S.) |
917
280 2424 / 401 500 6570 |
|
|
U.S. Media Enquiries:Sam Brown Inc.
Healthcare Communications |
|
Christy CurranMike Beyer |
615
414 8668312 961 2502 |
GW Pharmaceuticals (NASDAQ:GWPH)
Historical Stock Chart
From Aug 2024 to Sep 2024
GW Pharmaceuticals (NASDAQ:GWPH)
Historical Stock Chart
From Sep 2023 to Sep 2024