GW Pharmaceuticals submits Type II Variation Application to the European Medicines Agency (EMA) to expand the use of EPIDYOLE...
March 13 2020 - 7:00AM
GW Pharmaceuticals plc (Nasdaq: GWPH) (“GW”, “the Company” or “the
Group”), a world leader in discovering, developing and
commercialising cannabinoid prescription medicines, today announces
the submission of a Type II Variation Application to the European
Medicines Agency (EMA) seeking approval of EPIDYOLEX®,
(cannabidiol) oral solution, for the treatment of seizures
associated with Tuberous Sclerosis Complex (TSC), a rare genetic
condition and a leading cause of genetic epilepsy. If approved,
this will be the third licensed indication for GW’s cannabidiol
oral solution in Europe.
“This submission to the EMA is an important step for GW and
furthers GW’s mission to bring innovative cannabinoid medicines to
patients with high unmet need,” said Chris Tovey, GW’s Chief
Operating Officer. “We look forward to working with the EMA to
demonstrate GW’s cannabidiol oral solution’s potential in this new
indication and hope to make this rigorously tested cannabis-based
medicine available to a new group of patients through a potential
approval in due course.”
TSC is a condition that causes mostly benign
tumours to grow in vital organs of the body including the brain,
skin, heart, eyes, kidneys and lungs, and in which epilepsy is the
most common neurological feature. TSC is typically diagnosed in
childhood.1
The Type II Variation Application is based on
data from a positive Phase 3 safety and efficacy study. The study
met its primary endpoint with patients treated with GW’s
cannabidiol oral solution 25 mg/kg/day experiencing a significantly
greater reduction from baseline in TSC-associated seizures compared
to placebo (49% vs 27%; p=0.0009). Results for the 50 mg/kg/day
dose group were similar, with seizure reductions of 48% from
baseline vs 26.5% for placebo (p=0.0018). All key secondary
endpoints were supportive of the effects on the primary endpoint.
The safety profile observed was consistent with findings from
previous studies, with no new safety risks identified.
ADDITIONAL INFORMATION
About Tuberous Sclerosis Complex
(TSC)Tuberous Sclerosis Complex (TSC) is a rare genetic
condition that has an estimated prevalence in the EU of 10 in
100,000.2 The condition causes mostly benign tumours to grow in
vital organs of the body including the brain, skin, heart, eyes,
kidneys and lungs and is a leading cause of genetic epilepsy.1,3
TSC often occurs in the first year of life with patients suffering
from either focal seizures or infantile spasms. It is associated
with an increased risk of autism and intellectual disability.1 The
severity of the condition can vary widely. In some children the
disease is very mild, while others may experience life-threatening
complications.4
About
EPIDIOLEX®/EPIDYOLEX®
(cannabidiol) oral
solutionEPIDIOLEX®/EPIDYOLEX® (cannabidiol) oral solution,
the first prescription, plant-derived cannabis-based medicine
approved by the U.S. Food and Drug Administration (FDA) for use in
the U.S. and the European Medicines Agency’s (EMA) for use in
Europe, is an oral solution which contains highly purified
cannabidiol (CBD). EPIDYOLEX received approval in Europe in
September 2019 for the treatment of seizures associated with
Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two
years of age or older in conjunction with clobazam. In the U.S.,
EPIDIOLEX was approved in June 2018 by the FDA and is indicated for
the treatment of seizures associated with LGS or Dravet syndrome in
patients two years of age or older. A supplemental New Drug
Application (sNDA) was submitted to the FDA in early 2020 for the
treatment of seizures associated with Tuberous Sclerosis Complex
(TSC). GW’s cannabidiol oral solution 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.
About GW Pharmaceuticals plc
Founded in 1998, GW is a biopharmaceutical company focused on
discovering, developing and commercialising novel therapeutics from
its proprietary cannabinoid product platform in a broad range of
disease areas. The Company’s lead product, EPIDIOLEX®/EPIDYOLEX®
(cannabidiol) oral solution is commercialised in Europe by GW, and
in the U.S. by the Company’s subsidiary, Greenwich Biosciences. The
Company has a strong pipeline of additional cannabinoid product
candidates, with late-stage clinical trials in autism,
schizophrenia, post-traumatic stress disorder (PTSD) and spasticity
associated with multiple sclerosis (MS) and spinal cord injury. For
further information, please visit www.gwpharm.com.
Enquiries |
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Stephen Schultz, VP Investor Relations, GW |
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UK, EU and ex-U.S. media enquiries |
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Mike Beyer |
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1 NIH Tuberous Sclerosis Fact Sheet.
https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Tuberous-Sclerosis-Fact-Sheet.
2 Prevalence and incidence or rare diseases: Bibliographic
data. https://www.orpha.net/orphacom/cahiers/docs/GB/Prevalence_of_rare_diseases_by_alphabetical_list.pdf3
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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