The U.S. Food and Drug Administration (FDA) approved BIMZELX® (bimekizumab-bkzx) for the treatment of moderate-to-severe hidradenitis suppurativa (HS) in adults, making it the first therapy approved to target both IL-17A and IL-17F, key drivers of inflammation in this chronic, painful skin condition. This marks the fifth approved indication for BIMZELX in the U.S., expanding therapeutic options for patients with immune-mediated diseases.

A New Era for a Debilitating Skin Disease

HS is a difficult-to-treat inflammatory condition characterized by painful nodules, abscesses, and draining tunnels that commonly appear in the armpits, groin, and buttocks. It affects approximately 1 in 100 people and has long lacked targeted, durable treatments. BIMZELX offers a novel mechanism of action and has demonstrated significant improvements in disease signs, symptoms, and quality of life in clinical trials.

The FDA approval is based on data from the BE HEARD I and BE HEARD II Phase 3 trials, which enrolled more than 1,000 participants. At Week 16, a significantly higher proportion of BIMZELX-treated patients achieved HiSCR50 and HiSCR75 response rates compared to placebo, with improvements sustained through Week 48. Safety results were consistent with previous BIMZELX studies and showed no new safety signals.

DelRicht Investigators Contribute to Trial Success

DelRicht Research proudly recognizes the contributions of Dr. Deirdre Hooper and Dr. Sarah Jackson of Audubon Dermatology in New Orleans, LA, and Dr. Ira Thorla of LA Dermatology Associates in Baton Rouge, LA, as key investigators in this pivotal trial. Drs. Hooper and Jackson have led more than 90 clinical trials with DelRicht since 2016, and Dr. Thorla has led 100+ trials since 2018, across a broad range of dermatologic conditions.

Their experience and leadership helped support the execution of this complex, multicenter study in a challenging therapeutic area, efforts that Marshall Morris, Partner at DelRicht Research, notes were essential to the trial’s success.

Raising the Standard of Care in HS

The approval of BIMZELX underscores the urgent need for more advanced treatment options in HS, a condition that significantly impacts physical and emotional well-being. UCB’s commitment to addressing unmet needs in immuno-dermatology has now extended relief to a patient population with limited previous options.

“This milestone highlights what’s possible when experienced sites, committed sponsors, and breakthrough science align,” said Marshall Morris, Partner at DelRicht Research. “We are proud of the contributions our investigators made in helping bring this innovative treatment to approval.”

“This milestone highlights what’s possible when experienced sites, committed sponsors, and breakthrough science align. We are proud of the contributions our investigators made in helping bring this innovative treatment to approval.”

— Marshall Morris, Partner at DelRicht Research

Learn More About BIMZELX for HS

BIMZELX is now available for patients with moderate-to-severe HS. To learn more about the study that contributed to the FDA Approval of BIMZELX, read the full manuscript.

DelRicht Research remains committed to accelerating new therapies by partnering with leading investigators, optimizing site performance, and delivering consistent quality across every trial.

Read the full press release from UCB.