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EPIDYOLEX® (cannabidiol): New PBS Listed treatment for seizures associated with Dravet syndrome

Date: 01 May 2021

Melbourne, Australia. Saturday 1st May, 2021
Chiesi Australia today announced that Epidyolex®, a cannabis-based medicine approved by the Therapeutic Goods Administration (TGA) for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older, will be available on the Pharmaceutical Benefits Scheme (PBS) from May 1, 2021.1,2


Dravet syndrome, is a rare and drug-resistant form of epilepsy presenting in the first year of life.3 Children and adults with Dravet syndrome experience severe symptoms, including repeated and prolonged seizures, cognitive and intellectual impairment.3


Professor Ingrid Scheffer, paediatric neurologist and epileptologist, and clinical researcher at Austin Health and the University of Melbourne said:

“Epidyolex® is an important addition to our treatment options for Dravet syndrome, which is a devastating form of epilepsy. The PBS listing of Epidyolex® is an important step towards making new treatment options available to patients.”

Graeme Shears, CEO Epilepsy Foundation, welcomed the new treatment option and improved access to medicines for Australians living with epilepsy.

“Dravet syndrome is one of the most severe and difficult to treat forms of childhood-onset epilepsy.” said Mr Shears. “The availability of Epidyolex® on the PBS is an important milestone for patients and their families who are affected by this rare, complex and life-long form of epilepsy.”

“We welcome the PBS listing of Epidyolex® and look forward to this important treatment option being made available for patients and families living with Dravet syndrome.”

“We are delighted to announce the PBS listing of Epidyolex® for the management of patients with Dravet syndrome in Australia. Our focus and ongoing commitment is to ensure Australian patients living with rare diseases such as Dravet syndrome can have access to affordable treatment options in a timely manner." said Chris Rossidis, General Manager, Chiesi Australia.

Chiesi Australia has partnered with UK-based pharmaceutical company and manufacturer of Epidyolex®, GW Pharmaceuticals, to make the treatment available in Australia.

“We are proud to make this medicine available to patients in Australia through our partnership with Chiesi Australia. The PBS listing is further proof that cannabis-based medicines can successfully go through a rigorous evaluation process to reach patients with an unmet need. GW is committed to generating highquality evidence to enable the registration and reimbursement of cannabis-based medicines for patients with rare diseases.” said Chris Tovey, Chief Operating Officer, GW Pharmaceuticals.

About Dravet Syndrome
Dravet syndrome is a rare and lifelong form of epilepsy that begins in the first year of life with frequent and/or prolonged seizures.3 The early seizures often happen when the infant has a fever or high temperature.3 Previously known as Severe Myoclonic Epilepsy of Infancy (SMEI), it affects 1 in 15,700 individuals.3 While seizures persist, other comorbidities such as developmental delay and abnormal electroencephalogram (EEGs) are often not evident until the second or third year of life.4

About Epidyolex®5
Epidyolex® contains cannabidiol, a medicine which can be used to treat epilepsy, a condition where someone has seizures. It is used in combination with other antiseizure medicines to treat seizures that occur with two rare conditions, called Dravet syndrome and Lennox-Gastaut syndrome. It can be used in adults, adolescents and children of at least 2 years of age.

Important Safety Information®5
The active ingredient of Epidyolex® is cannabidiol. Epidyolex® should not be taken if:
- you are allergic to cannabidiol or any of the other ingredients of this medicine listed in the Consumer Medicine Information
- if your doctor determines that you have certain abnormal liver blood tests.

Epidyolex® must not be given to children under the age of 2 years since there is no information on use in children below this age. Like all medicines, Epidyolex® can cause side effects, although not everybody gets them.


The following side effects could be very serious:
- high liver enzymes (transaminases elevations) seen in blood tests, which can be a sign of liver injury have been reported in patients receiving Epidyolex®
- people taking this medicine can have thoughts of harming or killing themselves. If you have these thoughts at any time, contact your doctor.

Very common side effects (may affect more than 1 in 10 people):
- feeling drowsy or sleepy
- decreased appetite
- diarrhoea
- fever
- feeling tired
- vomiting

Common side effects (may affect more than 1 in 100 people):
- lack of energy
- cold, sore throat
- respiratory tract infections (pneumonia, bronchitis)
- blood tests showing increases in levels of certain liver enzymes (which may be signs
- of liver damage)
- shaking of the body or parts of it
- feeling bad-tempered (irritable,aggressive)
- difficulty in sleeping
- cough
- rash
- increased appetite, weight loss
- drooling
- urinary tract infection
- agitation
- abnormal behaviour.

About Chiesi Australia
Chiesi Australia is the Australia-New Zealand division of the Chiesi Group, a global pharmaceutical company based in Parma, Italy. The Chiesi Group acquired Emerge Health in November 2019. The Chiesi Group (also known as Chiesi Farmaceutica) is an international research focused Group with over 80 years’ experience in healthcare, operating in 29 countries. The Group conducts research, develops treatment options and supplies innovative drugs to treat a wide range of conditions. The Group’s Research and Development Centre is based in Parma, Italy and coordinates the activities of four important R&D groups in France, USA, UK and Sweden to drive its own pre-clinical, clinical and registration programs. The Group continues to focus in areas of respiratory diseases, specialty care and rare diseases.

Additional Information
The information contained within this media release does not contain all the available information. It does not take the place of talking to a healthcare professional. Please speak to your doctor for further information about Dravet syndrome, Lennox-Gastaut syndrome or Epidyolex®. For a copy of the Consumer Medicine Information, please ask your healthcare professional.
In relation to this Chiesi Australia media announcement, no compensation was provided to Laureate Professor Ingrid Scheffer or Graeme Shears and the opinions expressed are their own.

For media inquiries please contact:
Rachel Barry, Red Havas. 0448 216 676 rachel.barry@redhavas.com
Emma Shipley, Red Havas. 0434 623 510 emma.shipley@redhavas.com

1. Pharmaceutical Benefits Scheme. http://pbs.gov.au
2. Epidyolex® Product Information. Date of revision 8 December 2020.
3. Dravet Syndrome, Epilespy Foundation, 2020. https://epilepsyfoundation.org.au/understandingepilepsy/ epilepsy-syndromes/dravet-syndrome/
4. Panayiotopoulos CP. The Epilepsies: Seizures, Syndromes and Management: Dravet Syndrome: Severe Myoclonic Epilepsy in Infancy. 2005:152-158.
5. Epidyolex® Consumer Medicine Information, 2020.

EPIDYOLEX® is a registered trademark of GW Pharmaceuticals. Distributed in Australia by Emerge Health Pty Ltd, a Chiesi Company. Suite 3, 22 Gillman Street, Hawthorn East, VIC. 3123, Australia. Tel: +61 3 9077 4486; Fax: +61 3 8672 0792; Email: customerservice.au@chiesi.com; Website: www.chiesi.com.au. Copyright © Emerge Health, a Chiesi Company 2020 CHIESI AUSTRALIA PTY LTD; All rights reserved, Date of Preparation: April 2021,