Dermatology Month in Review: September 2024

In the latest in the Month in Review series, the HCPLive team’s coverage of dermatology news is highlighted from September 2024. This month, a wide array of interviews and advancements in the field were reported on by the editorial team.

Some notable events include US Food and Drug Administration (FDA) decisions related to lebrikizumab and delgocitinib, as well as coverage of the Maui Derm NP+PA Fall 2024 conference in Nashville, Tennessee. During the latter, many clinicians and health care providers were interviewed on their presentations at the conference.

Here, we present a set of notable stories from September in the field of dermatology:

FDA News Updates

FDA Approves Lebrikizumab Treatment of Eczema Among Patients Aged 12 and Older

In a significant move by the FDA, the organization approved the targeted interleukin (IL)-13 inhibitor lebrikizumab-lbkz (EBGLYSS) for adults and children aged 12 years or older with moderate-to-severe atopic dermatitis which is not adequately controlled through topicals. This decision resulted from the positive findings observed in the ADvocate 1, ADvocate 2, and ADhere clinical studies.

“Many experience poor long-term disease control, and severe itch can significantly impact their daily lives," Jonathan Silverberg, MD, PhD, MPH, professor of dermatology at George Washington University School of Medicine and Health Sciences, said in a statement. “Today's FDA approval of (lebrikizumab) 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.”

FDA Accepts NDA for Delgocitinib Cream Treatment of Chronic Hand Eczema

In another example of September’s FDA news, LEO Pharma announced the FDA had accepted their New Drug Application (NDA) for delgocitinib cream indicated for individuals with chronic hand eczema (CHE). If the drug were to be approved, delgocitinib cream would be the first therapy for moderate to severe CHE approved within the US for adults.

This topical cream option for CHE is an investigational pan-Janus kinase (JAK) inhibitor designed specifically to inhibit the activation of JAK-STAT signaling. The acceptance of the regulatory submission followed phase 3 findings in the DELTA 1 and DELTA 2 clinical trials which evaluated twice-daily delgocitinib 2% versus a vehicle cream.

Conference News Highlights in September

Most Promising New Drugs for Hidradenitis Suppurativa, with Raj Chovatiya, MD, PhD

A wide array of informative talks were presented at the Maui Derm NP+PA Fall 2024 conference in Nashville. One such talk was followed by an interview with Raj Chovatiya, MD, PhD, clinical associate professor of medicine for the Rosalind Franklin University Chicago Medical School, who spoke with HCPLive about promising drug options for providers to introduce to those with hidradenitis suppurativa (HS).

In his interview, Chovatiya touched on the anti-IL17A biologic secukinumab as a recently-approved medication option. He spoke about other treatments in the pipeline, highlighting bimekizumab and izokipeb. Chovatiya also spoke about his view that anti-IL17 drugs represent the next wave of HS treatments.

Updates on Benzoyl Peroxide Use for Acne, with James Del Rosso, DO

In another post-presentation interview at Maui Derm NP+PA Fall, James Q. Del Rosso, DO, research director of JDR Dermatology Research in Las Vegas and president of the American Acne and Rosacea Society (ARS), highlighted updates related to the quality assurance organization Valisure’s report on concerning levels of the carcinogen benzene within benzoyl peroxide (BPO) products for acne.

The report has since not faced a response by FDA officials, though many clinicians and patients may be wondering about the safety of such skincare products. Del Rosso highlighted the fact that the Valisure report was followed by a decision to file their 8th US Food and Drug Administration Citizen Petition, though the petition has not yet been given a formal response.

Most Exciting New Therapies in Atopic Dermatitis, with Matthew Zirwas, MD

In another conference interview at Maui Derm NP+PA Fall, Matthew Zirwas, MD, director of the clinical trials and dermatitis center at Dermatologists of Greater Columbus, spoke about several notable elements of his presentation titled ‘Atopic Dermatitis and Itch Update 2024.’

“The most exciting new thing in atopic dermatitis, I'd say this year, is a new drug from Lilly which just got approved last week,” Zirwas said. “It's a drug that we've been watching for 10 years, and the generic name is lebrikizumab. The data started coming out in 2013 and it finally got its approval last week. There are a couple things that are unique and really worth knowing about this drug.”

Atypical Clinical Presentations of Blistering Disease, with Donna Culton, MD, PhD

Donna Culton, MD, PhD, professor of dermatology at the University of North Carolina at Chapel Hill, also gave an interview to HCPLive at Maui Derm NP+PA Fall, following her talk ‘Blistering Diseases: What’s the Diagnosis.’ The presentation provided attendees with a series of challenging cases designed to highlight atypical presentations of blistering conditions.

“I think with the atypical clinical presentations, the real takeaway is going to be that a biopsy for routine histology will not always help you, and you need to do the biopsy for direct immunofluorescence,” Culton said. “...Of course, always take the patient's history and do the exam, but if it comes to mind that it could be one of these non-blistering or atypical presentations, really think about the direct immunofluorescence.

Other Notable Studies

Positive Long Term Findings on Nemolizumab Observed for Atopic Dermatitis, Prurigo Nodularis

Another significant study in September suggested that nemolizumab (Nemluvio) led to continuous improvements in patients’ signs and symptoms of atopic dermatitis for more than a year. These 56-week findings were presented at the European Academy of Dermatology & Venereology Congress in Amsterdam, another September conference.

The data were the result of an interim analysis of the phase 3 ARCADIA long-term extension study and were announced by Galderma. They presented these data from the ARCADIA and OLYMPIA clinical trial programs, both of which evaluated nemolizumab’s efficacy among those with atopic dermatitis and prurigo nodularis.

For additional news covered as part of EADV 2024, view our latest conference postings here.