GW Pharmaceuticals receives European Commission approval for EPIDYOLEX® (cannabidiol) for the treatment of seizures associat...
2021年4月20日 - 7:30PM
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 Commission (EC) has approved the Type II variation
application for EPIDYOLEX® (cannabidiol) as an adjunctive treatment
of seizures associated with TSC, for patients two years of age and
older. This approval, which represents the third indication for
GW’s cannabidiol in Europe, paves the way for the expanded launch
of the medicine across Europe.
“This is an exciting moment for patients, and
their families, who are affected by this debilitating disease and
may benefit from this treatment. This approval is the result of the
continued dedication of GW and the physician and patient
communities to address this serious unmet medical need,” said
Justin Gover, GW’s Chief Executive Officer. “We now look forward to
working with each European member state to make EPIDYOLEX®
available to appropriate patients across Europe, as quickly as
possible.”
Dr. Volker Knappertz, GW’s Chief Medical
Officer, said, “We are excited by the news of this approval by the
European Commission and the benefits EPIDYOLEX could bring to the
community. The clinical data supporting EPIDYOLEX in TSC provides
hope of a better quality of life for patients. This medicine
provides more choice for physicians managing seizures associated
with TSC and has the potential to benefit the thousands of patients
who do not respond to the current standard of care.”
Professor Alexis Arzimanoglou, Coordinator of
the European Reference Network for Rare and Complex Epilepsies ERN
EpiCARE (University Hospitals of Lyon, France), added, “Those
suffering from TSC and those involved in their care will welcome
this European approval. Given the demonstrated efficacy and safety
profile of EPIDYOLEX, this important development could offer a
much-needed treatment option to those most in need.”
The approval is based on data from a positive
Phase 3 safety and efficacy study evaluating 25 mg/kg/day of GW’s
cannabidiol. 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 27% 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.
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.4
GW’s cannabidiol was originally approved by the
European Medicines Agency (EMA) in September 2019 under the
tradename 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.
The EC decision is valid in all 27 countries of
the European Union, alongside Norway, Iceland and
Liechtenstein.
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, and for adjunctive use to treat
seizures associated with TSC, 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 LGS, Dravet syndrome, and Tuberous Sclerosis Complex
(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
100,000.5 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.4,5
The onset of epilepsy in TSC often occurs in the first year of life
with patients initially suffering from predominantly 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.6,7
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- 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.
- 2 Boston Children’s Hospital.
https://www.childrenshospital.org/conditions-and-treatments/conditions/t/tuberous-sclerosis-tsc/symptoms-and-causes.
Accessed March 2021.
- Chu-Shore CJ, Major P, Camposano S, Muzykewicz D, Thiele EA.
The natural history of epilepsy in tuberous sclerosis complex.
Epilepsia 2010;51(7):1236–41.
- NIH Tuberous Sclerosis Fact Sheet.
https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Tuberous-Sclerosis-Fact-Sheet.
- Prevalence and incidence of rare diseases: Bibliographic data.
https://www.orpha.net/orphacom/cahiers/docs/GB/Prevalence_of_rare_diseases_by_alphabetical_list.pdf
- TS Alliance Website. https://www.tsalliance.org/. Accessed
March 2021
- 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.
GW Pharmaceuticals (NASDAQ:GWPH)
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