GW Pharmaceuticals receives positive CHMP opinion for EPIDYOLEX® (cannabidiol) for use as treatment of seizures associated w...
2021年2月26日 - 9:15PM
GW Pharmaceuticals plc (Nasdaq: GWPH) (“GW”, “the Company” or “the
Group”), a world leader in discovering, developing and delivering
regulatory approved cannabis-based medicines, today announces that
the European Medicines Agency’s (EMA) Committee for Medicinal
Products for Human Use (CHMP) has adopted a positive opinion on the
Company’s Type II variation application for
EPIDYOLEX
® (cannabidiol) as an adjunctive
treatment of seizures associated with Tuberous Sclerosis Complex
(TSC), for patients two years of age and older.
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
“Epilepsy is reported in more than 90% of
individuals with Tuberous Sclerosis Complex (TSC), and over 60% of
those with seizures associated with TSC do not respond to standard
anti-epileptic medicines.2,3 Today’s positive CHMP opinion brings
us one step closer to a potentially life-improving new treatment
option for these patients for whom EPIDYOLEX may be appropriate,”
said Justin Gover, GW’s Chief Executive Officer. “This decision
represents another important step for GW as we look to expand the
medicine’s label in Europe. If approved, this represents the third
licensed indication for GW’s medicine, broadening patient access to
this rigorously tested cannabis-based medicine.”
Professor Helen Cross, Honorary Consultant in
Paediatric Neurology at Great Ormond Street Hospital for Children
NHS Foundation Trust, said, “This debilitating disease affects tens
of thousands of patients in Europe, many of whom may benefit from
alternative treatment options to achieve adequate seizure control.
This decision, and the clinical data supporting the use of
EPIDYOLEX in this challenging condition, offers real hope to the
patients, their parents and physicians that battle this condition
and the seizures it brings every day.”
Carla Fladrowski and Micaela Rozenberg,
Co-Chairs of the European Tuberous Sclerosis Complex Association,
added, “The lives of individuals with TSC and their families are
seriously impacted by drug-resistant epilepsy; TSC Associations
together are therefore resolute in their search for successful
therapies to help manage a condition that is so difficult to
control. We are extremely hopeful of the potential benefits that
this desperately needed new treatment option could bring to our
community, including the positive impact it could have not only on
quality of life but also the burden of the disease itself.”
The CHMP’s positive opinion is based on data
from a positive Phase 3 safety and efficacy study evaluating 25
mg/kg/day of GW’s cannabidiol (oral solution). The study met its
primary endpoint, which was the reduction in seizure frequency
compared to baseline of cannabidiol vs placebo, with seizure
reduction of 49% in patients taking cannabidiol 25 mg/kg/day
compared with 24% for placebo (p=0.0009). 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.
Dr. Volker Knappertz, GW’s Chief Medical
Officer, said, “We are delighted to have been able to demonstrate
the potential EPIDYOLEX has in treating seizures associated with
TSC through this regulatory review and in our conversations with
the CHMP. We now look forward to working with the European
Commission to gain approval for this label expansion to broaden
access to this medicine across the thousands of European patients
who need new treatment options.”
The CHMP’s recommendation will now be reviewed
by the European Commission (EC), which has the authority to approve
medicines for use in the 27 countries of the European Union (EU)
alongside Norway, Iceland and Liechtenstein. The EC is expected to
make a final decision on the Type II Variation Application in
approximately two months.
GW’s cannabidiol (oral solution) was originally
approved by the EMA and received marketing authorisation in
September 2019 under the trade name EPIDYOLEX® as an adjunctive
therapy for seizures associated with Lennox-Gastaut Syndrome (LGS)
or Dravet syndrome, in conjunction with clobazam, for patients two
years of age and older.
ADDITIONAL INFORMATION
About GW Pharmaceuticals plcGW
Pharmaceuticals (GW), and U.S. subsidiary Greenwich Biosciences, is
a UK-based global biopharmaceutical company that has established a
world-leading position in cannabinoid science and medicine. Founded
over two decades ago in response to significant unmet patient need,
patients remain our key focus and improving their quality of life,
our motivation. GW’s pioneering work has led to the regulatory
approval of world first, potentially life improving, cannabis-based
medicines. Our continued dedication has resulted in the treatment
of thousands of patients with our medicines around the world. For
further information, please visit www.gwpharm.co.uk
About EPIDIOLEX®/EPIDYOLEX®
(cannabidiol)EPIDIOLEX®/EPIDYOLEX® (cannabidiol), 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 Commission (EC) for use in Europe, is an oral
solution which contains highly purified cannabidiol (CBD). In the
U.S., EPIDIOLEX® is indicated for the treatment of seizures
associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome or
Tuberous Sclerosis Complex (TSC) in patients one year of age and
older. 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
in patients two years and older. In September 2020, EPIDYOLEX® was
approved by the Australian Therapeutic Goods Administration (TGA)
for use in Australia for the treatment of seizures associated with
LGS or Dravet syndrome in patients two years of age and older.
EPIDYOLEX® has received Orphan Drug Designation from the European
Medicines Agency (EMA) for the treatment of seizures associated
TSC.
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
100,000.4 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.1,5
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.6
Enquiries |
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GW Pharmaceuticals
plc |
|
Scott Giacobello, Chief Financial
Officer |
+1 760 795 2200 |
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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
Nabbout R, Belousova E, Benedik MP, et al. Epilepsy in tuberous
sclerosis complex: Findings from the TOSCA Study. Epilepsia Open.
2019 Mar; 4(1): 73–84.3 Boston Children’s Hospital.
https://www.childrenshospital.org/conditions-and-treatments/conditions/t/tuberous-sclerosis-tsc/symptoms-and-causes.
Accessed November 2020. 4 Prevalence and incidence or rare
diseases: Bibliographic data.
https://www.orpha.net/orphacom/cahiers/docs/GB/Prevalence_of_rare_diseases_by_alphabetical_list.pdf
5 TS Alliance Website. https://www.tsalliance.org/. Accessed
November 2020.6 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.
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