Dermatology Times September 2024 Recap

Clearances, Approvals, Updates, and Recommendations

Denileukin Diftitox-cxdl Gains NCCN Category 2A Recommendation for Cutaneous T-cell Lymphoma Treatment

Citius' recently-approved Lymphir has been added to the National Comprehensive Cancer Network's Clinical Practice Guidelines in Oncology.

FDA Approves Lebrikizumab-lbkz for Moderate to Severe Atopic Dermatitis

Ebglyss is now approved for children and adults aged 12 years and older.

FDA Approves UCB's Bimekizumab-bkzx for Psoriatic Arthritis

Bimzelx was also approved for non-radiographic axial spondyloarthritis and ankylosing spondylitis.

Two Major Regulatory Milestones Announced for Delgocitinib for CHE

Announcements from both the FDA and the EC were supported by 2 clinical trials that evaluated the safety and efficacy of delgocitinib cream.

FDA Accepts Roflumilast Foam sNDA for Scalp and Body Psoriasis

The FDA has set a PDUFA target action date of May 22, 2025.

Big Studies and Big Data

Study Outlines Prurigo Nodularis and Psychiatric Comorbidities

The review found that patients with PN are approximately 1.3 times more susceptible to depression and 1.9 times more likely to experience anxiety.

LEO Pharma Presents Prevalence, Severity, and Treatment CHECK Data for Chronic Hand Eczema

The data was presented at the European Society of Contact Dermatitis in Dresden, Germany, this week.

Abrocitinib Shows Promise for Prurigo Nodularis

The JAK1 inhibitor provided significant relief for 2 patients with refractory PN.

Phase 3 LIBERTY-CUPID Study C Trial for Dupilumab Meets Primary, Secondary Endpoints for Chronic Spontaneous Urticaria

These positive data will support US regulatory submission by end of 2024.

Sanofi Reports High Efficacy in Dupilumab for BP

New study results show promise in dupilumab for bullous pemphigoid, with 59% of patients avoiding disease relapse.

BD2-Selective BET Inhibitor VYN202 Demonstrates Positive Safety and Tolerability in Phase 1a Trial

The subsequent MAD portion of the study has commenced dosing. Results are anticipated in Q4.

Market and Pharma News, Drug Watch

Phase 2 Trial Begins for EVO756 in Chronic Inducible Urticaria

The phase 2 trial for EVO756, targeting mast cell-related CIndU, is now underway at 15 US study sites.

IBI363 Monotherapy Granted Fast Track Designation in US for Advanced Melanoma

The PD-1/IL-2α bispecific antibody fusion protein is intended for patients with unresectable locally advanced or metastatic melanoma.

Arcutis Enrolls Last Participant in ARQ-255 Trial for AA

Arcutis' study of ARQ-255 aims to address the lack of FDA-approved topical treatments for alopecia areata, a condition affecting roughly 1 in 500 people.

Organon to Acquire Dermavant Sciences and Tapinarof Cream

Dermavant’s sNDA for tapinarof cream 1% for AD is still under review with the FDA.

Strides for Skin Health Equity

Preclinical Medical Students Perform Similarly in Evaluating, Diagnosing Dermatological Diseases in Varying Skin Types

Researchers reported that second-year students were more likely to identify dermatological conditions, particularly in White patients.

Lebrikizumab Shows Promise for Patients with Skin of Color and AD

The IL-13 inhibitor, recently FDA-approved for moderate to severe AD, reached all primary endpoints in the study focusing on patients with skin of color.

Importance of APPs in Treating and Understanding AD

Researchers analyzed APPs treatment and perceptions on AD in studies focusing on patient satisfaction and patients with skin of color.

Diversifying Psoriasis Research to Benefit the Population

Zelma Chiesa Fuxench, MD, MSCE, FAAD, and Mona Shahriari, MD, FAAD, discuss the lack of research into psoriasis in skin of color, the absence of diversity in clinical trial populations, and where dermatology as a discipline can go from here.

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