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The (TGA) has approved new autoinjectors for the emergency treatment of anaphylaxis (acute severe allergic reactions) due to insect stings, food or other allergens,¹ with 鈥� Anapen 500, Anapen 300 and Anapen 150 Junior (Anapen Junior) adrenaline (epinephrine) added to the Australian Register of Therapeutic Goods (ARTG).

The approval means that Australians weighing 60 kg and over living with anaphylaxis can now access a 500 mcg adrenaline autoinjector dose.

(A&AA) CEO Maria Said welcomed the TGA approval of the autoinjector, citing its ability to offer choice to prescribers and their patients.

鈥淚t 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,鈥� Said stated.

鈥淗aving the Anapen 500 mcg dose available to those weighing 60 kg and over in Australia is an important step forward. 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.

鈥淧reviously, 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,鈥� Said explained.

鈥淗aving another supplier guarantees an alternative device option, should we experience a shortage of one adrenaline injector or the other.鈥�

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 co-founder and Managing Director Martin Naef, the inclusion of Anapen on the ARTG represents a major milestone in meeting a key finding of the .

鈥淥ne 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,鈥� Naef said.

鈥淲e are excited to be the only company in Australia offering a complete product line for all Australians 鈥� from children weighing 15 kg right up to adults weighing 60 kg or more.

鈥淭his marks an important innovation milestone in the management of allergy and anaphylaxis in this country, and reinforces Allergy Concepts鈥� commitment to providing more treatment options and solutions to Australian healthcare professionals and their patients.鈥�

References

1. Australian Government Department of Health, Items recommended between ordinary meetings (November 2020 - March 2021). 2021.
2. NSW Government Health. Allergies and Anaphylaxis. 2015 [cited March 2021]; Available from:
3. NPS MedicineWise. Adrenaline autoinjector (Anapen) for acute allergic anaphylaxis. 2010 [cited March 2021]; Available from:
4. Allergy & Anaphylaxis Australia. What is Anaphylaxis? 2020 [cited March 2021]; Available from:
5. Australasian Society of Clinical Immunology and Allergy (ASCIA). Adrenaline (Epinephrine) Autoinjectors Frequently Asked Questions (FAQ). 2021 [cited March 2021]; Available from: