FDA approves Bimzelx for adults with moderate to severe hidradenitis suppurativa
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Key takeaways:
- Bimzelx is the first and only approved interleukin-17F and -17A inhibitor in this indication.
- The approval was based on results from the BE HEARD trials.
The FDA has approved Bimzelx for the treatment of moderate to severe hidradenitis suppurativa in adults, UCB announced in a press release.
“Prior to the approval of Bimzelx for the treatment of hidradenitis suppurativa (HS), treatments included various classes of antibiotics, retinoids, steroids, surgery, hormonal therapies and biologics. However, these treatment options may not work for every person,” Christopher Sayed, MD, professor of dermatology at the University of North Carolina at Chapel Hill and an investigator in the BE HEARD trials, told Healio. “This is reflected in my clinical practice with less than half of patients feeling happy with treatment results with the medications that are currently FDA-approved to treat HS.”
This approval makes Bimzelx (bimekizumab-bkzx, UCB) the first and only approved interleukin-17F and -17A inhibitor in this indication, providing another much-needed treatment in dermatologists’ armamentarium.
“While there are no head-to-head studies in HS between bimekizumab and the two other approved biologics, Bimzelx is the only approved treatment that targets two critical cytokines, IL-17A and IL-17F, of which the latter is a key driver in HS that is overexpressed and more prevalent than IL-17A,” Sayed said.
The approval was supported by data from the BE HEARD trials, which were two phase 3 studies that found Bimzelx to be effective and safe for the treatment of adults with moderate to severe HS.
In the trials, a higher proportion of Bimzelx-treated patients reached a 50% or greater improvement in the signs and symptoms of HS as measured by Hidradenitis Suppurative Clinical Response (HiSCR) vs. those treated with placebo by week 16. More patients treated with Bimzelx also achieved a 75% improvement in their HS according to HiSCR compared with those treated with placebo in the same time frame.
Outcomes achieved with Bimzelx were sustained through week 48. Furthermore, Bimzelx maintained a similar safety profile from previous trials with no new adverse events observed.
“Clinical decisions on when to initiate Bimzelx will be made by treating physicians, depending on the needs of their individual patients, but given the strength of the efficacy data, particularly at weeks 48 and 96, it will be my preferred first-line therapy for most patients,” Sayed told Healio.
Editor’s note: Quotes from Sayed were added on Nov. 21, 2024.
Perspective
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The approval of bimekizumab for patients with moderate to severe HS is incredibly exciting news given the limited number of approved therapies that are currently available for the HS community. Patients will now have access to a medication that has demonstrated strong depth and durability of response in large phase 3 trials, and clinicians have another tool in their arsenal to utilize. This approval speaks to the burning hope from the HS community for continued research for effective and safe treatments for those who are living with this oftentimes debilitating condition.
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