Dermatology Times February 2024 Recap

Clearances, Approvals, Updates, and Recommendations

Japan Approves Dupilumab for Chronic Spontaneous Urticaria

Japan is the first country in the world to approve dupilumab for the treatment of chronic spontaneous urticaria (CSU).

Lifileucel Receives FDA Accelerated Approval for Advanced Melanoma

Lifileucel is a tumor-derived autologous T cell immunotherapy.

ICYMI: FDA Approves Third Interchangeable Humira Biosimilar Simlandi

Simlandi (adalimumab-ryvk) joins Pfizer’s Abrilada (adalimumab-afzb) and Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) as an interchangeable Humira biosimilar.

B-Raf Inhibitor Receives FDA Orphan Drug Designation for Treatment of EGFRI-Induced Acneiform Rash

Most patients undergoing EGFRI treatment for cancer will develop acneiform lesions, yet no drug is currently approved by the FDA for their prevention or treatment.

BLAs and NDAs

Dermavant Submits sNDA to FDA for Tapinarof Cream 1% to Treat AD Down to 2 Years

Tapinarof cream demonstrated highly statistically significant improvement in the primary end point of vIGA-AD treatment success over vehicle at week 8.

Citius Resubmits BLA of Denileukin Diftitox for Relapsed or Refractory Cutaneous T-Cell Lymphoma

The resubmission follows the Complete Response Letter Citius received from the US FDA in July of 2023.

FDA Accepts Galderma’s BLA for Nemolizumab for the Treatment of Prurigo Nodularis and Atopic Dermatitis

The FDA has also granted nemolizumab Priority Review for prurigo nodularis.

Big Studies and Big Data

Targeted Oral Peptide JNJ-2113 Led to Significant PASI, IGA Responses in Phase 2b Trial for Plaque Psoriasis

Data from the FRONTIER 1 clinical trial were recently published in the New England Journal of Medicine.

Trust 2 Study Validates DermTech’s 2-GEP 99% Negative Predictive Value

The 2-GEP test is made of 2 biomarkers, LINC00518 and PRAME.

First US Consensus Published on Uniform Nomenclature and Diagnosis for Neuropathic Pruritus

Shawn Kwatra, MD, shares insights into neuropathic pruritus’ debilitating effects on patients and how clinicians can use unified nomenclature.

Shedding LITE on At-Home Phototherapy Treatment for Psoriasis

Get a sneak peek ahead of AAD about the LITE study’s patient-centered design, routine care integration, and diverse participant inclusion, offering a cost-effective option in psoriasis treatment.

Rilzabrutinib Rapidly Reduces Itch Severity in Adults with Chronic Spontaneous Urticaria

Late-breaking phase 2 data was presented at the 2024 American Academy of Allergy, Asthma and Immunology Annual Meeting.

Expert Insights Into the Relationship Between the Hippo Pathway and Extensive Fibrosis in HS

Researchers from the University of Michigan and Almirall found that the profibrotic fibroblast response in HS can be modulated through inhibition of the Hippo pathway.

Integrated Data From BRAVE-AA1 and BRAVE-AA2 Trials Supports Efficacy of Baricitinib Over 104 Weeks in Alopecia Areata

Long-term treatment showed increased efficacy in patients who responded partially in week 52, indicating the importance of extended therapy for maximizing benefits in certain individuals.

Market and Pharma News, Drug Watch

Almirall, Centre for Genomic Regulation Partner to Identify Molecular Pathways and Biomarkers for Atopic Dermatitis Treatments

The partnership is focused on exploring innovative therapeutic strategies to address AD.

First Patient Dosed in Phase 2a Trial of AX-158 for Psoriasis

Artax announced that safety and efficacy data is expected in the second half of the year.

Almirall Enters License Agreement With Novo Nordisk for Rights to IL-21 Blocking Monoclonal Antibody NN-8828

Almirall now possesses the rights to develop and commercialize NN-8828, particularly in immune inflammatory dermatological diseases.

New Topical Agent for Alopecia to Enter Phase 2 Trials

Data on the phase 1 trial of the small molecule agent for treatment of androgenetic alopecia and other forms of hair loss will be presented at the AAD meeting in March.

Strides for Skin of Color

Improving Representation of Skin of Color in Dermatology

Miranda Uzoma Ewelukwa, MD, FAAD, reviews how skin of color representation has evolved in dermatology, however, more advocacy is still needed.

Hair and Skin Publications From Sub-Saharan Africa Are Steadily Increasing, Researchers Report

Researchers involved in the review said this increase may help lead to more patient education and more tailored products for patients from this region.

Adewole (Ade) Adamson, MD, MPP: Systemic Racism, Patient Access, and Advancing Health Equity

Adamson recently shared with Dermatology Times about the significance of Vaseline's Mended Murals initiative and the role of dermatologists in improving patient access.

Delivering on Diversity in Clinical Trials: Getting Started

Susan Taylor, MD, believes in training more investigators that serve diverse populations to enhance clinical trials. Here are a few resources to get started in clinical trials.

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