GW Pharmaceuticals and Greenwich Biosciences Announce FDA Acceptance of sNDA Filing with Priority Review for EPIDIOLEX® (can...
March 31 2020 - 7:00AM
GW Pharmaceuticals plc (Nasdaq: GWPH), the world leader in the
science, development, and commercialization of cannabinoid
prescription medicines, along with its U.S. subsidiary Greenwich
Biosciences, Inc., today announced that the U.S. Food and Drug
Administration (FDA) has accepted for filing with Priority Review
its recently submitted supplemental New Drug Application (sNDA) for
the use of EPIDIOLEX® (cannabidiol) CV to treat seizures
associated with Tuberous Sclerosis Complex (TSC). The PDUFA
(Prescription Drug User Fee Act) goal date for completion of the
FDA review of the EPIDIOLEX sNDA is July 31, 2020. EPIDIOLEX is
already approved for the treatment of seizures associated with
Lennox-Gastaut syndrome (LGS) or Dravet syndrome, two rare and
difficult to treat conditions of childhood-onset epilepsy.
“We are pleased with the FDA’s acceptance of our
EPIDIOLEX sNDA filing with Priority Review, an action that
underscores the unmet need for new treatment options for patients
with TSC, a rare and severe childhood-onset disease,” said Justin
Gover, GW’s Chief Executive Officer. “More than 60% of individuals
with TSC do not achieve seizure control with standard
anti-epileptic drug treatments. Today’s news is therefore important
for TSC patients and their clinicians, and we look forward to
working with the FDA during the review process to expand the
EPIDIOLEX product label for use in TSC.”
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 sNDA accelerates the timing of the FDA
review of the application to a six month period compared to a
standard review of ten months.
About Tuberous Sclerosis Complex
(TSC)Tuberous sclerosis complex (TSC) is a rare genetic
condition that affects approximately 50,000 individuals in the U.S.
and nearly one million people worldwide.1 At least two children
born each day will develop TSC, with an estimated prevalence of one
in 6,000 newborns.5 The condition causes mostly benign tumors to
grow in vital organs of the body including the brain, skin, heart,
eyes, kidneys and lungs 2 and is a leading cause of genetic
epilepsy.3 TSC often occurs in the first year of life as either
focal seizures or infantile spasms1 and is associated with an
increased risk of autism and intellectual disability.4 The severity
of the condition can vary widely. In some children the disease is
very mild, while others may experience
life-threatening complications.6 Epilepsy is present in about
85% of patients with TSC and may progress to become intractable to
medication.1,2,3 More than 60% of individuals with TSC do not
achieve seizure control4 with standard treatments such as
antiepileptic drugs, epilepsy surgery, ketogenic diet, or vagus
nerve stimulation2 compared to 30-40 percent of individuals with
epilepsy who do not have TSC who are drug resistant.5,6
About GW Pharmaceuticals plc and
Greenwich Biosciences, Inc.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. The Company’s
lead product, EPIDIOLEX® (cannabidiol) oral solution, CV, is
commercialized in the U.S. by its U.S. subsidiary Greenwich
Biosciences for the treatment of seizures associated with
Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two
years of age or older. This product has received approval in the
European Union under the tradename EPIDYOLEX®. The Company has
submitted a supplemental New Drug Application (sNDA) to the U.S.
Food and Drug Administration (FDA) to expand the indication for
Epidiolex to include seizures associated with Tuberous Sclerosis
Complex (TSC), for which it has reported positive Phase 3 data, and
is carrying out a Phase 3 trial in Rett syndrome. The Company has a
deep pipeline of additional cannabinoid product candidates, in
particular nabiximols, for which the Company is advancing multiple
late-stage clinical programs in order to seek FDA approval in the
treatment of spasticity associated with multiple sclerosis and
spinal cord injury, as well as for the treatment of PTSD. The
Company has additional cannabinoid product candidates in Phase 2
trials for autism and schizophrenia. For further information,
please visit www.gwpharm.com.
About EPIDIOLEX® (cannabidiol) oral
solution, CVEPIDIOLEX® (cannabidiol) oral solution, CV, a
pharmaceutical formulation of highly purified cannabidiol (CBD), is
the first in a new class of anti-epileptic medications with a novel
mechanism of action, and the first prescription, plant-derived
cannabis-based medicine approved by the U.S. Food and Drug
Administration (FDA). In the U.S., Epidiolex is indicated for the
treatment of seizures associated with Lennox-Gastaut syndrome (LGS)
or Dravet syndrome in patients two years of age or older. A
supplemental New Drug Application (sNDA) has been submitted to the
FDA for the treatment of seizures associated with tuberous
sclerosis complex (TSC). Epidiolex has received approval in the
European Union under the tradename EPIDYOLEX® for adjunctive use in
conjunction with clobazam to treat seizures associated with LGS and
Dravet syndrome. Epidiolex/Epidyolex has received Orphan Drug
Designation from the FDA and the EMA for the treatment of seizures
associated with Dravet syndrome, LGS and TSC, each of which are
severe childhood-onset, drug-resistant syndromes.
Important Safety InformationImportant safety
information for Epidiolex is available
at Epidiolex.com.
Forward-looking statementThis
news release contains forward-looking statements that reflect GW's
current expectations regarding future events, including statements
regarding our goal of bringing Epidiolex® to patients with seizures
associated with Tuberous Sclerosis Complex (TSC), the potential for
Epidiolex to serve as a new treatment option for patients with
seizures associated with TSC, the clinical benefits
of Epidiolex, and the timing and outcomes of regulatory
decisions. Actual events could differ materially from those
projected herein and depend on a number of factors, including
(inter alia), the risks and uncertainties which 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.
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 |
___________________________1 TS Alliance, What is TSC?
https://www.tsalliance.org/about-tsc/what-is-tsc/. Accessed April
15, 2019.2 NIH Tuberous Sclerosis Fact Sheet.
https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Tuberous-Sclerosis-Fact-Sheet.
Accessed November 19, 2019.3 TS Alliance Website.
https://www.tsalliance.org/. Accessed November 19, 2019.4 de Vries
PJ, Belousova E, Benedik MP, et al. TSC-associated neuropsychiatric
disorders (TAND): findings from the TOSCA natural history study.
Orphanet J Rare Dis. 2018;13(1):157.5 Kwan P., Brodie M.J. Early
identification of refractory epilepsy. N. Engl. J.
Med. 2000;342(5):314–319.6 French JA. Refractory epilepsy:
clinical overview. Epilepsia. 2007;48 Suppl 1:3-7.
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