Dermatology Times October 2024 Recap

Clearances, Approvals, Updates, and Recommendations

FDA Approves sNDA for Actinic Keratosis Drug Dosage Expansion

The expanded dosage aims to provide healthcare providers with greater flexibility in treating larger or multiple areas affected by AK.

Fourth Ustekinumab Biosimilar, Otulfi, Approved in US

Otulfi from Formycon and Fresenius Kabi was approved simultaneously in the US and the European Union. In the US, it will launch in February 2025.

FDA Clears Accure’s Laser System for Long-Term Treatment of Acne

This new indication adds to existing clearance of a non-drug treatment for mild to severe inflammatory acne vulgaris.

FDA Approves 320 mg Bimekizumab Pre-Filled Syringe and Autoinjector

The new delivery systems for bimekizumab-bkzx represent an upgrade over previous 1 mL options, reducing the frequency of injections required.

Health Canada Approves Roflumilast Foam 0.3% for Patients 9 Years and Older With Seborrheic Dermatitis

This represents the second approval of Zoryve outside the US.

Big Studies and Big Data

Promising Long-term Results for ESK-001 in Psoriasis

The company plans to release full 52-week OLE data for ESK-001 in early 2025, building on positive interim results.

Late-Breaking Data: 40-Week Efficacy and Safety of Oral Povorcitinib for Prurigo Nodularis

Shawn Kwatra, MD, presented the Incyte data at EADV 2024.

Significant Proportion of Patients With AD Maintain Stable EASI With Tralokinumab Treatment

More than half of treatment responders maintained stable EASI ≤ 7, according to a poster from EADV.

New LEVEL UP Period 2 Data Shows Patients Who Switched From Dupilumab to Upadacitinib Achieved Higher Treatment Targets in AD

Christopher Bunick, MD, PhD, presented the latest period 2 data at Fall Clinical 2024.

Final ECZTEND Study Results Confirm Long-Term Safety and Efficacy of Tralokinumab for Moderate-to-Severe Atopic Dermatitis

Adbry achieved EASI-75 in 92.9% and IGA 0/1 in 66.7% of AD patients, with a strong safety profile.

Benvitimod is Safe and Effective for Palmoplantar Pustulosis, New Study Finds

The nonsteroid 1% cream treatment demonstrated good response and tolerability in patients with PPP.

Market and Pharma News, Drug Watch

UCB Announces Head-to-Head Trial Comparing Bimekizumab and Risankizumab

This marks the first head-to-head trial of an IL-17A/F inhibitor against an IL-23 inhibitor in psoriatic arthritis treatment.

BREAKING NEWS: Additional Study Confirms Reports of Benzene Presence, Formation in Benzoyl Peroxide Products at Room Temperature

New peer-reviewed research published in the Journal of Investigative Dermatology examined 111 products at room temperature.

LEO Pharma's Delgocitinib Launches for Chronic Hand Eczema in Germany

Germany is now the first country to launch the topical treatment for adults with moderate to severe CHE.

Almirall Completes Decentralized Regulatory Approval Procedure for Efinaconazole in Europe

Efinaconazole demonstrated enhanced efficacy in treating nail fungal infections, thanks to its high penetration capability and low keratin binding.

Strides for Skin Health Equity

Analyzing Efficacy and Safety in Diverse Clinical Trials: New Roflumilast Data

After releasing promising data from several clinical trials, Burnett discussed the importance of studying efficacy and safety across diverse populations.

Disparities in Hidradenitis Suppurativa: A Closer Look at Skin of Color Populations

A recent review found clinical trials for HS lack diversity, limiting understanding of treatment efficacy for SOC populations.

New Treatments Enhance Care for Diverse Range of Patients With Psoriasis

Historically, research and clinical practice often have overlooked the distinct manifestations and treatment needs of patients with skin of color who have psoriasis.

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