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Dermatology Month in Review | October 2024

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Key Takeaways

  • FDA cleared Accure Laser System for long-term treatment of inflammatory acne vulgaris using a 1726 nm laser wavelength.
  • Ustekinumab-srlf (IMULDOSA), a biosimilar to STELARA, was approved for chronic inflammatory diseases, demonstrating comparable pharmacokinetics and efficacy.
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In this Month in Review summary, some of the most notable advancements and developments in the field of dermatology were highlighted.

Dermatology Month in Review | October 2024

In the latest iteration of HCPLive’s Month in Review series, the editorial team’s coverage of developments in the field of dermatology has been highlighted from October 2024. A plethora of news and the latest advancements in the field were covered in October, as well as new data featured in conference coverage.

This review highlights developments related to the US Food and Drug Administration (FDA) as well as coverage of the 44th Annual Fall Clinical Dermatology Conference in Las Vegas, Nevada. For this month’s review, samples of both of these categories were highlighted to provide readers with a sense of the month’s most notable dermatology news.

In the following list, the team presents a set of notable developments from October covered in the field of dermatology:

FDA News

FDA Clears Long-Term Laser Treatment for Inflammatory Acne Vulgaris

Accure Acne, Inc., announced its receiving of FDA Clearance K242035 for the long-term treatment of individuals suffering from mild-to-severe inflammatory acne vulgaris, specifically using its ‘Accure Laser System.’

The Accure Laser System is a treatment designed using the unique 1726 nm laser wavelength. The technology includes proprietary technology which may help to precisely control thermal gradient depth for the purposes of targeting patients’ sebaceous gland. Acne is known to be 1 of the most commonly observed inflammatory skin conditions, and severity of the condition, patient characteristics, and disease morphology must be considered prior treatment selection.

FDA Approves Ustekinumab (STELARA) Biosimilar for Chronic Inflammatory Diseases

The FDA approval of ustekinumab-srlf (IMULDOSA) was also announced in October. The drug is a biosimilar to ustekinumab (STELARA) and indicated for such chronic inflammatory conditions as Crohn’s disease, psoriatic arthritis (PsA), psoriasis, and ulcerative colitis.

The biosimilar came from Accord BioPharma and following its comprehensive development program, highlighting comparability between its pharmacokinetics, safety, efficacy, and tolerability to that of STELARA, it was validated to adhere to the FDA’s guidelines for biosimilar products.

FDA Approves 3 Tubes of Aminolevulinic Acid Hydrochloride for Actinic Keratosis

In another piece of FDA news, Biofrontera Inc. announced the organization’s approval of raising of the maximum dosage of aminolevulinic acid hydrochloride (Ameluz) for patients with actinic keratosis from a single tube to 3 tubes for each of their treatments.

Following a February letter issued by the FDA suggesting that there had not been any filing review issues found following Biofrontera’s submission of their supplemental New Drug Application (sNDA) for the raising of the drug’s maximum dosage, the approval took place.

Samples of Conference Coverage

New Phase 3 Data Shows High Rate of Atopic Dermatitis Clearance Using Tapinarof Cream 1%

In 1 development in conference news, new ADORING 3 study findings were presented at the Fall Clinical Dermatology Conference suggesting that tapinarof cream 1% (Vtama) for those aged 2 years and older with atopic dermatitis resulted in complete skin clearance among the majority of subjects within only 48 weeks. The cream itself, an aryl hydrocarbon receptor agonist, was assessed in ADORING 3 following the prior ADORING 1 and ADORING 2 studies.

“In the ADORING long-term extension study, (tapinarof) cream demonstrated a high rate of complete disease clearance, with more than half of enrolled adults and children entering with or achieving a vIGA-AD score of zero at least once, on monotherapy,” Robert Bissonnette, MD, FRCPC, Innovaderm Research’s chief executive officer, said in a statement. “Moreover, upon reaching complete disease clearance and ceasing treatment, patients stayed clear or almost clear for an average period of approximately 80 consecutive days.”

New ‘Level Up’ Data on Upadacitinib (Rinvoq) for Atopic Dermatitis, with Christopher Bunick, MD, PhD

Another notable highlight from the Fall Clinical Dermatology Conference was an interview with Christopher Bunick, MD, PhD, an associate professor with the Yale School of Medicine, about his team’s latest phase 3b/4 clinical data from the ‘Level Up’ study.

The new findings specifically regarded the use of upadacitinib (Rinvoq) as a therapy for patients with atopic dermatitis. The therapy showed significant efficacy among those with atopic dermatitis who had not responded to dupilumab, achieving Eczema Area Severity Index improvement of 75% (EASI-75) among nearly 80% of subjects by the 32-week mark.

What Are Some Other Methods To Manage Skin Cancer Outside of Biopsies?

Following a talk at the Fall Clinical Dermatology Conference titled ‘Beyond the Biopsy: Other Methods To Help Us Manage Skin Cancer,’ the HCPLive editorial team interviewed the 2 presenters regarding the contents: Neal Bhatia, MD, and Laura Korb Ferris, MD, PhD. Ferris, professor at the University of Pittsburgh Clinical and Translational Science Institute and the director of the clinical trials unit at the UPMC department of dermatology, spoke along with Bhatia, who serves as director of clinical dermatology at Therapeutics Clinical Research and chief medical editor for Practical Dermatology.

Some of the most significant highlights from the presentation included their urging of dermatologists to be involved in all stages of skin cancer management, as opposed to only severe cases. Some of the key advancements they touched upon in skin cancer treatment included hedgehog inhibitors for basal cell carcinoma and cemiplimab for squamous cell carcinoma.

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