New adrenaline autoinjector for acute allergic anaphylaxis now TGA approved

SYDNEY, Australia (Thursday, March 25, 2021) – Allergy Concepts today announced the inclusion of Anapen 500^®, Anapen 300^® and Anapen 150 Junior^® (Anapen Junior) adrenaline (epinephrine) autoinjectors on the Australian Register of Therapeutic Goods (ARTG) for the emergency treatment of anaphylaxis (acute severe allergic reactions) due to insect stings, food or other allergens.¹

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Significantly, for the first time, this TGA approval arms Australians weighing 60kg and over living with anaphylaxis, with access to a 500mcg adrenaline autoinjector dose. Among the world’s first countries to have granted approval for use of the Anapen 500mcg dose, Australia is now positioned at the forefront of global innovation in allergy and anaphylaxis management.

Allergy & Anaphylaxis Australia (A&AA) CEO, Ms Maria Said, Sydney welcomed the TGA approval of the autoinjector, citing its ability to offer both prescribers and their patients alike, with choice.

“It is important for an individual at risk of anaphylaxis, and their treating doctor, to discuss adrenaline injector device options, and to choose a device that best suits their needs.

“Having the Anapen 500mcg dose available to those weighing 60kg and over in Australia, is an important step forward,” stated Ms Said.

“The listing of Anapen also provides welcome relief to those at risk of anaphylaxis, who have long been reliant upon one device, and severely impacted during manufacturing delays, product recalls, or supply shortages.

“Previously, Australians needed to use expired devices for life-threatening emergencies if they occurred during stock shortages. Furthermore, those who were diagnosed with anaphylaxis during shortages were left with no life-saving medication,” Ms Said explained.

“Having another supplier guarantees an alternative device option, should we experience a shortage of one adrenaline injector or the other.”

Anaphylaxis is a severe and potentially life-threatening allergic reaction that should always be treated as a medical emergency.² Adrenaline is the first-line emergency treatment for anaphylaxis,^3,4 and administration can reduce the risk of hospital admission (after treatment in the emergency department), and death in those at significant risk of anaphylaxis.³

Adrenaline autoinjectors contain a single, fixed dose of adrenaline, and have been designed for use by non-healthcare professionals, including the individual patient, should they be well enough.⁵

According to Allergy Concepts Founder and Managing Director, Mr Martin Naef, Sydney, the inclusion of Anapen on the ARTG represents a major milestone in meeting a key finding of the Parliamentary Inquiry into Allergies and Anaphylaxis.⁶

“One of the key Committee findings from the Parliamentary Inquiry was the need for the introduction of alternative adrenaline autoinjectors to the Australian market, to prevent future stock shortages. The introduction of Anapen represents the first significant step towards addressing this serious public health issue.

“We are excited to be finally providing a new treatment option for Australians living with potentially life-threatening anaphylaxis. Furthermore, Australians weighing 60kg or more will now have access to a specific 500mcg adrenaline autoinjector dose for the first time,” said Mr Naef.

“This marks an important innovation milestone in the management of allergy and anaphylaxis in this country, and reinforces Allergy Concepts’ commitment to providing more treatment options and solutions to Australian healthcare professionals, and their patients.”

The Pharmaceutical Benefits Advisory Committee (PBAC) recommended the General Schedule Authority Required Pharmaceutical Benefits Scheme (PBS) listing of Anapen 300^®, Anapen 500^® and Anapen 150 Junior^® at their November 2020 meeting.⁷

About Allergy Concepts

Allergy Concepts is a privately owned Australian company specialising in allergy treatments. The company aims to help healthcare professionals and their patients access cutting-edge allergy medicines and treatment protocols, to help alleviate all allergy-related conditions.⁹

Founded by a team with substantial allergy-related pharmaceutical and biotechnology company experience, the Allergy Concepts team is passionate about allergy and immunology, and is dedicated to introducing more treatment options and solutions to Australian healthcare professionals, and their allergic patients.⁹

About Anapen^®

Anapen^® contains a pre-filled adrenaline (epinephrine) syringe in an intuitive auto-injection device (auto-injector) manufactured by Bioprojet Pharma, Europe. Anapen auto-injector is intended for immediate self-administration by an individual with a history of anaphylaxis, and is designed to deliver a single dose of 150/300/500 micrograms adrenaline (epinephrine).⁸

Each Anapen device is designed to deliver a single, intramuscular dose of adrenaline to the outer-mid thigh,³ and has a shelf life of up to 24 months. The device should be stored below 25° C, but not refrigerated.  Anapen has a significantly different administration technique to other auto-injector devices. The autoinjector is triggered by pushing a red button with the thumb.³  Device training and education is available through Allergy Concepts, A&AA and the Australasian Society of Clinical Immunology and Allergy (ASCIA), for pharmacists and healthcare professionals to facilitate the use of this new device for patients and carers.

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