Bimekizumab now TGA approved for hidradenitis suppurativa

The decision will ‘raise the standard of care and alleviate the burden of this lesser-known, painful and debilitating condition’.

Bimekizumab has been added to the ARTG for the treatment of moderate to severe hidradenitis suppurativa, biopharmaceutical company UCB announced this week.

Bimekizumab is a humanised monoclonal antibody which selectively inhibits interleukin 17F and interleukin 17A, two cytokines that play an important role in driving the inflammatory processes underlying HS. 

The TGA’s decision was based on the results of the BE HEARD I and BE HEARD II phase three trials, in which 16 weeks of bimekizumab treatment increased the proportion of patients who displayed a HS clinical response of at least 50% (HiSCR50) compared to placebo. Improvements in HiSCR75 and quality of life were also reported as part of these trials.

Data presented at last year’s European Academy of Dermatology and Venerology Congress suggested the HS clinical response improvements following bimekizumab treatment lasted for up to 12 months.

Associate Professor John Frew, dermatologist and director of research at The Skin Hospital in Sydney, welcomed the opportunity to offer bimekizumab as a treatment to his patients.

“With bimekizumab we have a therapy that achieves improvements in high threshold endpoints of HiSCR75, HiSCR90 and quality of life, over a sustained period,” he said in a statement.

Dr Diana Rubel, a dermatologist at Woden Dermatology in the ACT, described the listing as “a step forward in our ability to manage this challenging condition in the future”.

General manager at UCB Australia Selina Clifford said the TGA’s decision represented “a significant step forward in our mission to raise the standard of care and alleviate the burden of this lesser-known, painful and debilitating condition”.

Bimekizumab received TGA registration for the treatment of moderate to severe plaque psoriasis who were eligible for systemic therapy or phototherapy in 2022. Last year the indications for its use were extended to include active psoriatic arthritis and active axial spondylarthritis.

HS affects less than 1% of Australians, and is characterised by painful nodules, abscesses and draining tunnels in the skin of axillary, inguinal, genitoanal and inframammary areas.