UCB’s Bimzelx granted MHRA approval to treat hidradenitis suppurativa in adults

12 Jun 2024
pmlive.com
Clinical ResultDrug Approval
UCB’s Bimzelx granted MHRA approval to treat hidradenitis suppurativa in adults
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Source: PMLiVE
UCB’s Bimzelx (bimekizumab) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat adults with active moderate-to-severe hidradenitis suppurativa (HS).
The approval applies to patients who have had an inadequate response to conventional systemic HS therapy and was granted through the International Recognition Procedure, which takes into account prior authorisations from other regulatory partners.
HS is an inflammatory skin disease that causes nodules, abscesses and pus-discharging fistulas, with many patients experiencing flare-ups as well as severe pain.
Administered as a subcutaneous injection, Bimzelx works by selectively inhibiting two key cytokines driving inflammatory processes and is already approved by the MHRA to treat certain patients with plaque psoriasis, psoriatic arthritis and axial spondyloarthritis.
“There have been limited new treatment options available in recent years for HS and [this] approval offers a new and differentiated treatment choice for people living with moderate-to-severe disease,” said Dr John Ingram, clinical reader and consultant dermatologist, Cardiff University.
The latest authorisation is supported by positive data from the late-stage BE HEARD I and BE HEARD II studies, which evaluated the efficacy and safety of Bimzelx in more than 1,000 adults with moderate-to-severe HS.
Results showed that a significantly higher proportion of patients treated with Bimzelx versus placebo achieved a 50% or greater improvement in HS signs and symptoms at week 16, as measured by HiSCR50, with Bimzelx treatment also resulting in clinically meaningful improvements in HiSCR75.
Clinical responses were sustained to week 48, UCB said, adding that the safety profile of Bimzelx was consistent with safety data seen in previous trials.
Funmi Oluwa, interim managing director, UCB UK, said the company was “delighted with the speed of [Bimzelx’s] approval in Great Britain”.
The decision comes less than two months after Bimzelx was approved by the European Commission for the same HS patient population.
Emmanuel Caeymaex, executive vice president, immunology solutions and head of US, UCB, said at the time of the April announcement: “We are proud to bring the first and only approved medicine targeting IL-17A and IL-17F to the HS community.
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