TGA approval positions Australia at the forefront of innovation in allergy and anaphylaxis management

Pharma News: Allergy Concepts announced the TGA approval of autoinjectors for the emergency treatment of anaphylaxis and is awaiting PBS listing.

Significantly, for the first time, this TGA approval off Anapen 500, Anapen 300 and Anapen 150 Junior (Anapen Junior) adrenaline (epinephrine) autoinjectors arms Australians weighing 60kg and over living with anaphylaxis (acute severe allergic reactions), 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, 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. Adrenaline is the first-line emergency treatment for anaphylaxis, and administration can reduce the risk of hospital admission (after treatment in the emergency department), and death in those at significant risk of anaphylaxis.

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.

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

“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 the only company in Australia offering a complete product line for all Australians – from children weighing 15kg right up to adults weighing 60kg or more,” 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.