The year 2024 has proven to be a remarkable one for the dermatologic field. Marked by groundbreaking drug approvals and advancements that are transforming patient care and outcomes, these innovative developments are reshaping the future of treatment. With cutting-edge therapies addressing previously unmet needs, these new approvals are not only setting new standards for the industry but also offering hope and improved quality of life for patients. Here’s a look at some of the most significant 2024 drug approvals.
BIMZELX ® (bimekizumab-bkzx) for Hidradenitis Suppurativa
This November 2024 approval is a major breakthrough for patients long suffering with hidradenitis suppurativa (HS), a chronic, painful, and potentially debilitating inflammatory skin disease characterized by recurring abscesses and scarring. This new treatment offers a novel mechanism of action that addresses the inflammatory pathways implicated in moderate-to-severe HS. BIMZELX is the first and only treatment specifically designed to selectively inhibit both interleukin 17F (IL-17F) and interleukin 17A (IL-17A), making it a unique and effective option.
Christopher G. Bunick, MD, PhD, LiVDerm Advisory Board Member and associate professor of dermatology and translational biomedicine at the Yale University School of Medicine in New Haven, Connecticut, said, “The approval of bimekizumab is a landmark step in the treatment of hidradenitis suppurativa using multi-targeted biologics. Neutralization of Il-17A and Il-17F, the science of which was published earlier this year in JID, will raise the standards of care for HS patients and deliver much needed clinical, psychological, and social improvements.”
EBGLYSS ™ (lebrikizumab-lbkz) for Atopic Dermatitis
In September, the U.S. Food and Drug Administration (FDA) approved EBGLYSS for the treatment of moderate-to-severe atopic dermatitis (AD) in adults and children over 12 years. EBGLYSS 250 mg/2 mL injection is a targeted IL-13 inhibitor that may be used with or without topical corticosteroids. In clinical trials, 38% of patients achieved clear or almost-clear skin at 16 weeks, compared to 12% with placebo. Additionally, 10% saw results as early as four weeks. EBGLYSS also demonstrated sustained efficacy in long-term studies, offering a reliable option for patients who struggle with chronic symptoms.
Jonathan I. Silverberg, M.D., Ph.D., M.P.H., professor of dermatology at George Washington University School of Medicine and Health Sciences in Washington, DC, and first author of the New England Journal of Medicine manuscript summarizing EBGLYSS clinical trials, has said, “Patients still struggle to control their moderate-to-severe atopic dermatitis with currently available therapies. Many experience poor long-term disease control, and severe itch can significantly impact their daily lives. Today’s FDA approval of EBGLYSS is a big win for patients, as we now have a new first-line biologic treatment option for moderate-to-severe disease when topical prescriptions aren’t enough.”
Nemluvio® (nemolizumab) for Prurigo Nodularis
Approval for Nemluvio for the treatment of prurigo nodularis (PN) in adults came in August 2024. This pre-filled pen for subcutaneous injection is the first approved monoclonal antibody specifically inhibiting IL-31 signaling, a neuroimmune cytokine that drives multiple disease mechanisms in PN.
PN, often marked by persistent, intense itch and skin nodules covering large body areas, affects up to 181,000 people in the United States. It is a significant burden on patients, often leading to disrupted sleep and reduced quality of life. During trials, Nemluvio offered clinically meaningful improvements in both itch and skin nodules by Week 16.
Shawn G. Kwatra, MD, University of Maryland Department of Dermatology, noted, “I’m delighted that Nemluvio has received U.S. FDA approval and I’m looking forward to offering this treatment option to the prurigo nodularis patients in my practice who are in desperate need of fast relief from itch, which negatively impacts their quality of life. By inhibiting the signaling of IL-31, Nemluvio addresses a key driver of prurigo nodularis, safely and effectively improving itch as well as skin nodules.”
LEQSELVI™ (deuruxolitinib) for Alopecia Areata
July 2024 saw the approval of LEQSELVI for the treatment of severe alopecia areata (AA) in adults. This twice-daily oral selective inhibitor of JAK1 and JAK2 targets pathways contributing to hair loss in severe AA.
An autoimmune disease, AA causes the immune system to target hair follicles, leading to sudden hair loss on the scalp, face, and other areas. This condition often causes significant physical and emotional distress. During clinical trials, over 30% of patients taking LEQSELVI experienced 80% or more scalp hair coverage, and up to 25% regained almost all of their scalp hair by 24 weeks.
Natasha A. Mesinkovska, MD, PhD, Associate Professor and Vice Chair for Clinical Research of Dermatology, University of California, Irvine, said, “For many people with severe alopecia areata, early intervention with effective treatment is critical. An oral JAK that delivers proven results will be impactful for the alopecia areata community.”
Sofdra™ (sofpironium) for Primarily Axillary Hyperhidrosis
Approved in June 2024, Sofdra offers new hope for patients with primarily axillary hyperhidrosis. This topical gel, containing 12.45% sofpironium bromide, is the first chemical entity approved for this condition and is intended for once-daily use with an applicator to avoid hand contact.
In clinical trials, 85% of patients experienced significant improvement in hyperhidrosis symptoms. David M. Pariser, MD, founding board member of the International Hyperhidrosis Society, remarked, “The approval of Sofdra is terrific news for the hyperhidrosis community, which has been frustrated by the lack of effective and convenient treatment options,” said David Pariser, MD, in a news release. The availability of a new treatment alternative that is topical, well-tolerated, effective, and easy to use is truly exciting and would be welcomed amongst patients and physicians.”
ZELSUVMI™ (berdazimer topical gel, 10.3%) for Molluscum Contagiosum
In January 2024, approval was given to ZELSUVMI for the treatment of molluscum contagiosum in adults and children aged one year and older. A nitric oxide-releasing agent, ZELSUVMI became the second FDA-approved treatment for molluscum contagiosum but stands out because it allows for at-home application.
Molluscum contagiosum, a highly contagious viral skin infection affecting approximately 6 million Americans annually, is characterized by skin-colored to red lesions with a central, umbilicated viral core. Mark D. Kaufmann, MD, FAAD, said, “The approval of ZELSUVMI is a breakthrough, marking the first time clinicians can treat molluscum with an efficacious topical medication that patients can apply themselves.”
What These Approvals Mean for Dermatology Professionals
These new 2024 approvals are more than just milestones; they represent transformative opportunities for both patients and clinicians. By providing innovative treatments that address unmet needs and improve outcomes, these therapies are reshaping the dermatologic landscape. Dermatologists and other healthcare professionals can now offer more personalized, effective options, bringing hope and new possibilities to patients.
Looking Ahead
As we look to 2025, the promise of continued innovation in dermatology is bright. With the development of novel therapies and groundbreaking research, patients and practitioners can anticipate even more advancements that will further elevate the standard of care in the field.
Sources:
- UCB Receives U.S. FDA Approval for BIMZELX® (bimekizumab-bkzx) as the First IL-17A and IL-17F Inhibitor for Adults with Moderate-to-Severe Hidradenitis Suppurativa. (n.d.). [Press release]. https://www.prnewswire.com/news-releases/ucb-receives-us-fda-approval-for-bimzelx-bimekizumab-bkzx-as-the-first-il-17a-and-il-17f-inhibitor-for-adults-with-moderate-to-severe-hidradenitis-suppurativa-302311330.html
- FDA Approves Bimekizumab for Adults with Moderate to Severe HS. (n.d.). Dermatology Times. https://www.dermatologytimes.com/view/fda-approves-bimekizumab-for-adults-with-moderate-to-severe-hs
- FDA Approves Lilly’s EBGLYSSTM (lebrikizumab-lbkz) for Adults and Children 12 Years and Older with Moderate-to-Severe Atopic Dermatitis. (n.d.). [Press release]. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglysstm-lebrikizumab-lbkz-adults-and
- Galderma receives U.S. FDA approval for Nemluvio® (nemolizumab) for adult patients living with prurigo nodularis. (n.d.). Galderma. https://www.galderma.com/news/galderma-receives-us-fda-approval-nemluvior-nemolizumab-adult-patients-living-prurigo
- U.S. FDA Approves LEQSELVITM (deuruxolitinib), an Oral JAK Inhibitor for the Treatment of Severe Alopecia Areata. (n.d.). [Press release]. https://www.prnewswire.com/news-releases/us-fda–approves-leqselvi-deuruxolitinib-an-oral-jak-inhibitor-for-the-treatment-of-severe-alopecia-areata-302207222.html
- https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02819259-6A1212299
- FDA Approves Sofpironium (Sofdra) as First and Only Chemical Entity for Primary Axillary Hyperhidrosis. (n.d.). Dermatology Times. https://www.dermatologytimes.com/view/fda-approves-sofpironium-sofdra-as-first-and-only-chemical-entity-for-primary-axillary-hyperhidrosis
- U.S. Food and Drug Administration Approves ZELSUVMITM as a First-in-Class Medication for the Treatment of Molluscum Contagiosum. (n.d.). [Press release]. https://investor.ligand.com/news-and-events/press-releases/news-details/2024/U.S.-Food-and-Drug-Administration-Approves-ZELSUVMI-as-a-First-in-Class-Medication-for-the-Treatment-of-Molluscum-Contagiosum/default.aspx
- FDA Approves Berdazimer Gel, 10.3% for the Treatment of Molluscum Contagiosum
