Dermatology Times June 2024 Recap

Clearances, Approvals, Updates, and Recommendations

FDA Approves Expanded Use of Tirbanibulin for Actinic Keratosis

Phase 3 clinical trial results showed that the safety and tolerability profiles were consistent with those observed in the original pivotal trials.

MoonLake Immunotherapeutics Announces FDA, EMA Support of Furthering Phase 3 Sonelokimab for PsA

The phase 3 IZAR program will evaluate the efficacy and safety of sonelokimab in patients with psoriatic arthritis for a 1 year duration.

FDA Approves Tralokinumab Autoinjector for Adults With Moderate to Severe Atopic Dermatitis

LEO Pharma's Adbry, a single-dose autoinjector, is expected to become available to patients in the coming months.

FDA Approves Sofpironium (Sofdra) as First and Only Chemical Entity for Primary Axillary Hyperhidrosis

Botanix Pharmaceuticals announced the approval of its sofpironium topical gel, 12.45% for adults and children ages 9 and older.

Health Canada Authorizes Lebrikizumab for Moderate to Severe Atopic Dermatitis in Patients 12 Years and Older

Authorization for Eli Lilly's Ebglyss is based on positive results from the ADvocate 1, ADvocate 2, and ADhere studies.

FDA Grants Investigational New Drug Clearance for Ensemble No.2 for Phase 1 Atopic Dermatitis Trial

Ensemble No.2, or ENS-002, is an investigational live biotherapeutic product first detected by Concerto Biosciences using its kChip technology.

Big Studies and Big Data

Efficacy of Dupilumab in Treating Atopic Hand and Foot Dermatitis

The trial results indicated 3 significant improvements across all AHFD subtypes with dupilumab treatment compared to placebo.

Q&A: Alexa Kimball, MD, MPH, Talks BE HEARD Data for Hidradenitis Suppurativa

UCB recently announced phase 3 BE HEARD I and II trial results on bimekizumab for treating moderate to severe HS were published in The Lancet.

Moderna and Merck Announce New 3-Year Date for mRNA-4157 Combined With Pembrolizumab for High-Risk Stage III/IV Melanoma

Phase 3 trials have been initiated in patients with high-risk melanoma.

Upadacitinib Demonstrates Continued Improvements in Patients With Moderate to Severe AD Through 140 Weeks

Improvements in patient-reported outcomes were higher among patients treated with upadacitinib 30mg versus 15mg.

Late-Breaker: Roflumilast Cream 0.15% Demonstrates Continued Improvement in AD Symptoms Through 56 Weeks

Roflumilast cream 0.15% is being evaluated for patients with mild to moderate atopic dermatitis down to 6 years.

Late-Breaker: Upadacitinib Demonstrates Superiority Over Dupilumab in All Ranked Secondary End Points of Head-to-Head AD Study

The phase 3b/4 LEVEL-UP study assessed adolescents and adults with moderate to severe atopic dermatitis.

Late-Breaker: Positive 52-week Data for Rademikibart in Patients with AD

The data, presented at RAVE 2024, continued a positive trend, building upon strong phase 1 results of rademikibart for patients with AD.

Lebrikizumab Maintains EASI 90 Responses up to 38 Weeks After Discontinuation

The post-hoc analysis evaluated the relationship between lebrikizumab serum concentration levels and sustained clinical response after lebrikizumab discontinuation.

Market and Pharma News, Drug Watch

Upadacitinib Available for Pediatric Patients with pJIA, PsA

Upadacitinib is now available as a tablet or an oral solution for patients 2 years and older with pJIA as well as PsA.

VYNE Therapeutics Initiates Phase 2b Trial of BET Inhibitor VYN201 for Vitiligo

The primary efficacy endpoint is the proportion of subjects achieving at least a 50% improvement in the Facial Vitiligo Area Scoring Index.

First Patients Dosed with VYN202 for Inflammatory Diseases

VYNE Therapeutics Inc. shared that top-line data from the trial is expected in the second half of 2024.

Strides for Skin Health Equity

Visual Racism and Racial Bias Persist in Dermoscopy Imaging

In one study, less than 5% of images from a HAM10000 database came from patients with darker skin types.

Research Finds Poor Awareness and Photoprotective Behaviors Among Individuals With Albinism in Nigeria

Individuals in Uyo, Nigeria, with albinism are at great risk of developing photodermatoses due to a lack of photoprotection and awareness of photoprotective behaviors.

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