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.
This approval makes Bimzelx (bimekizumab-bkzx, UCB) the first and only approved interleukin-17F and -17A inhibitor in this indication.
“We are thrilled that with this milestone Bimzelx is now FDA-approved for the treatment of adults with moderate to severe hidradenitis suppurativa, a chronic and painful disease affecting approximately one in 100 people,” Emmanuel Caeymaex, executive vice president, head of patient impact and chief commercial officer of UCB, said in the press release. “This is the fifth patient population who may benefit from Bimzelx in the U.S.”
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.
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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