MHRA approves UCB’s Bimzelx for adult hidradenitis suppurativa

UCB's Bimzelx (bimekizumab) has recently received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for treating adults with active moderate-to-severe hidradenitis suppurativa (HS). This approval is directed at patients who have not responded adequately to traditional systemic HS treatments and was granted through the International Recognition Procedure, which considers previous authorizations from other regulatory bodies.

Hidradenitis suppurativa is a chronic inflammatory skin condition characterized by the formation of nodules, abscesses, and pus-discharging fistulas. Patients often endure flare-ups and severe pain, significantly impacting their quality of life. Bimzelx, administered via subcutaneous injection, functions by selectively inhibiting two cytokines that drive inflammatory processes. It is already approved by the MHRA for treating plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis.

Dr. John Ingram, a clinical reader and consultant dermatologist at Cardiff University, highlighted the significance of this approval, noting that there have been limited new treatment options for HS in recent years. He emphasized that Bimzelx offers a new and differentiated choice for individuals with moderate-to-severe HS.

The latest approval is underpinned by positive results from the BE HEARD I and BE HEARD II studies, which assessed the efficacy and safety of Bimzelx in over 1,000 adults with moderate-to-severe HS. The findings revealed that a significantly higher proportion of patients treated with Bimzelx achieved a 50% or greater improvement in HS signs and symptoms by week 16, compared to those receiving a placebo. This improvement was measured using the HiSCR50 metric. Additionally, Bimzelx treatment led to clinically meaningful improvements in HiSCR75. UCB reported that these clinical responses were sustained up to week 48, and the safety profile of Bimzelx was consistent with data from previous trials.

Funmi Oluwa, interim managing director of UCB UK, expressed the company's satisfaction with the swift approval of Bimzelx in Great Britain. This decision follows closely on the heels of the European Commission's approval of Bimzelx for the same patient population less than two months prior.

Emmanuel Caeymaex, executive vice president of immunology solutions and head of US operations at UCB, remarked during the April announcement that they are proud to introduce the first and only approved medication targeting IL-17A and IL-17F to the HS community. He expressed confidence in Bimzelx's potential to transform the care for individuals living with moderate-to-severe HS.