Dermatology Times April 2024 Recap

Clearances, Approvals, Updates, and Recommendations

J-Code for Ycanth Officially Launches Today

The permanent J-code for the molluscum contagiosum treatment is now live.

FDA Issues Alert on Counterfeit Botox: What Dermatology Clinicians Need to Know

The FDA has released guidelines for clinicians and tips to identify the distinguishing features of counterfeit products.

ICYMI: US FDA Recently Approves Stelara Biosimilar Ustekinumab-aekn for Psoriasis, Psoriatic Arthritis

Last week, the US Food and Drug Administration approved biosimilar ustekinumab-aekn (Selarsdi; Alvotech and Teva) for psoriasis and PsA.

European Union Approves Bimekizumab to Treat HS

The European approval was based on data from the Phase III BE HEARD I and BE HEARD II trials.

FDA Issues Complete Response Letter for Abeona's Pz-cel for Epidermolysis Bullosa

The CRL indicates that the timing proposed for data submission would not allow enough time for the FDA to complete its review by the May 25 PDUFA date.

BLAs and NDAs

FDA Accepts Supplemental Biologics License Applications for Bimekizumab to Treat HS

The submission stems from promising results from the phase 3 BE HEARD I and BE HEARD II trials.

FDA Accepts Dermavant’s sNDA for Tapinarof Cream 1% for Adults and Children With AD

The FDA’s PDUFA date is expected in quarter 4 of 2024.

Big Studies and Big Data

Apremilast Demonstrates Consistent Safety and Efficacy in Children with Moderate to Severe Plaque Psoriasis at 52 Weeks

Loretta Fiorillo, MD, FRCPC, reviews key data points from the phase 3 SPROUT study.

Study Becomes First to Demonstrate Efficacy of Topical Isoniazid in Melasma

Study participants in the treatment group experienced an observable and significant decrease in melanin index scoring.

Surface Area of IL-23's Epitope Influences Short- and Long-Term Responses for IL-23 Inhibitors in Plaque Psoriasis

Risankizumab demonstrated the highest efficacy in PASI90 responses among analyzed IL-23 inhibitors.

Guselkumab Demonstrates Significant Improvement in Psoriasis Symptoms and HRQoL, Reduces Sexual Impairment and Stigmatization

Data stems from week 28 results of the German G-EPOSS study evaluating the effectiveness of guselkumab in skin health, quality of life, sexuality, and stigmatization.

ASLAN Announces Positive Phase 2 Results of Eblasakimab in Dupilumab-Treated Patients With AD

Sixty percent of dupilumab-treated patients with AD treated with 400mg of eblasakimab weekly achieved EASI-90 after 16 weeks.

Upadacitinib Outperforms Dupilumab in Primary and Secondary End Points in Head-to-Head AD Study

In LEVEL-UP, upadacitinib demonstrated superiority over dupilumab in achieving EASI-90 and little to no itch at week 16.

Market and Pharma News, Drug Watch

Incyte and CMS Collaborate to Develop Povorcitinib in Numerous Chinese Regions

Povorcitinib is being evaluated for non-segmental vitiligo, hidradenitis suppurativa, prurigo nodularis, asthma, and chronic spontaneous urticaria.

Soligenix and European Medicines Agency Settle on Design of Second Placebo-Controlled Trial of HyBryte in CTCL

The agreement for a second confirmatory trial comes after a successful phase 3 FLASH study that yielded positive outcomes and efficacy.

ARCA Biopharma and Oruka Therapeutics Agree to Merger

The merger will focus on advancing Oruka’s portfolio of novel biologics for the treatment of chronic skin diseases.

Pelthos Therapeutics Launches to Accelerate Commercialization of Treatment for Molluscum Contagiosum

The new launch is set to bring berdazimer topical gel, 10.3% to adults and pediatric patients over the age of 1 with molluscum contagiosum faster.

MoonLake Immunotherapeutics and Komodo Health to Partner to Improve Research on Inflammatory Skin Conditions

MoonLake’s sonelokimab is being evaluated for hidradenitis suppurativa, psoriasis, and psoriatic arthritis.

Strides for Skin Health Equity

Mona Shahriari, MD, FAAD: 'The Days of Paternalistic Medicine Are Gone'

Shahriari shares pearls and considerations from her sessions at the recent Diversity in Dermatology conference.

Botulinum Toxin, Dermal Fillers Generally Effective and Well-Tolerated in Skin of Color Populations

In a literature review, researchers found data supporting the efficacy and safety of fillers in patients with skin of color, particularly for populations where is there is limited data.

Experts Pen 12 Implementable Steps For Addressing Gender Inequity In Academic Dermatology

Addressing gender inequity in academic dermatology involves strengthening societies, celebrating female dermatologists, promoting leadership, and equitable representation, authors wrote.

LC-OCT Demonstrates Potential For Rapid, Effective Visualization of Inflammatory Conditions Across Skin Types

LC-OCT provided quick, noninvasive assessment of skin conditions with detailed imaging aids diagnosis and treatment, especially for patients with darker skin types.

Addressing Disparities in Skin-Aging Prevention Among Women of Color

A recent survey covered topics including skin-aging prevention, care-seeking behavior, trust in professionals, and more.

Colorimetric Scale Offers Practical Classification in Clinical Assessment of Skin of Color

Skin cancer risk classification lacks reliability for darker skin tones and fails in evaluating cutaneous medical conditions or cosmetic interventions, according to creators of the scale.

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