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PBS listing of Dupixent (dupilumab) for severe atopic dermatitis

From 1st March 2021, Dupixent (dupilumab) is listed on the Pharmaceutical Benefits Scheme (PBS) in Australia for the treatment of patients, 12 years and above, with severe atopic dermatitis, who have failed to respond to optimally prescribed topical treatments.

Dupixent is a fully-human monoclonal antibody that inhibits the signaling of the interleukin4 (IL-4) and interleukin-13 (IL-13) proteins, and is not an immunosuppressant. Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis. Type 2 inflammation is the common denominator behind a range of lifelong diseases, including atopic dermatitis, asthma, and other allergic or atopic disorders, which appear to be disparate conditions but occur when the immune system overreacts to an allergen or pathogen.

Dupixent has been studied in more than 2,500 adult patients and 250 adolescent patients with moderate-to-severe atopic dermatitis. Dupixent is also the only systemic treatment for uncontrolled moderate-to-severe atopic dermatitis that has been studied for up to three years in adults. The long-term safety profile of Dupixent observed in adolescents was consistent with that seen in adults with atopic dermatitis. 

Dupixent is jointly developed by Sanofi and Regeneron under a global collaboration agreement.

In Australia, Dupixent is approved by the Therapeutic Goods Administration (TGA) to treat moderate-to-severe atopic dermatitis in patients aged 12 years and over who are candidates for chronic systemic therapy. The medicine is available on the PBS for eligible patients from 1st March 2021, but will remain available on private prescription for Australians with moderate atopic dermatitis. Dupixent is not intended for episodic use.

Further information is available here pdfDupixent® PBS listed for severe atopic dermatitis145.40 KB 

This news item was issued in March 2021 by Jill Smith, CEO of ASCIA, the peak professional body for clinical immunology and allergy in Australia and New Zealand.