Dermatology Times 2024: The Year’s Biggest Breakthroughs, Innovations, and Clinical Insights

FDA Clearances, Approvals, Updates, and Recommendations

FDA Approves Berdazimer Gel, 10.3% for the Treatment of Molluscum Contagiosum

The approval marks a milestone for patients ages 1 year of age and older who face the persistent, highly contagious condition.

FDA Updates Dupilumab Label With Hand, Foot Atopic Dermatitis Involvement

The FDA added efficacy and safety data for patients ages 12 years and older with uncontrolled moderate-to-severe atopic dermatitis with hand and/or foot involvement.

Lifileucel Receives FDA Accelerated Approval for Advanced Melanoma

Lifileucel is a tumor-derived autologous T cell immunotherapy.

FDA Approves Juvederm as the First and Only Hyaluronic Acid Dermal Filler for Use in Moderate to Severe Temple Hollowing

The approval also marks the first and only approved HA dermal filler approved in the US for use in the upper face.

FDA Approves Boehringer Ingelheim's Spesolimab-sbzo For Adults and Children With Generalized Pustular Psoriasis

The expanded approval of Spevigo follows the Chinese National Medical Products Administration’s approval for the injection for the reduction of occurrence of GPP.

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

LEO Pharma's Adbry is a single-dose autoinjector.

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.

FDA Approves Roflumilast Cream 0.15% For Atopic Dermatitis in Patients Aged 6 Years and Older

Patrick Burnett, MD, PhD, provided insights into the significance of Arcutis’ roflumilast cream 0.15% formulation and its impact on pediatric patients.

The FDA Approves Deuruxolitinib for Severe Alopecia in Adults

Along with the approval, Sun Pharma introduced an access program to assist eligible patients in starting and adhering to the treatment.

FDA Approves Denileukin Diftitox for Adults With Relapsed or Refractory Cutaneous T-Cell Lymphoma

The approval was supported by positive phase 3 data for Lymphir in this indication.

FDA Approves Nemolizumab for the Treatment of Prurigo Nodularis

Galderma’s nemolizumab became the first approved monoclonal antibody specifically inhibiting the signaling of IL-31.

FDA Approves Lebrikizumab-lbkz for Moderate to Severe Atopic Dermatitis

Ebglyss was 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.

FDA Approves Journey Medical’s DFD-29 for Rosacea

The minocycline hydrochloride extended release capsules (40 mg) represent a new standard of care for patients with rosacea.

FDA Approves Bimekizumab for Adults with Moderate to Severe HS

The drug became the first FDA-approved treatment for moderate to severe HS that selectively inhibits both IL-17A and IL-17F.

Big Studies and Big Data

Guselkumab Significantly Clears Scalp Psoriasis in Patients With Skin of Color in Phase 3b VISIBLE

The VISIBLE clinical program will create a longitudinal collection of more than 20,000 clinical images across all skin tones.

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

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

Benzene Found in Various Acne Products; Valisure Files Petition With FDA to Recall Treatments

High levels of the chemical benzene, which has been linked to cancer, were detected in numerous consumer acne products, including from major brands such as Proactiv, Clinique, and more.

Long-Term Safety and Efficacy of Largest Prurigo Nodularis Study Ever Conducted

Shawn Kwatra, MD, presented late-breaking data at AAD 2024 on the largest prurigo nodularis and nemolizumab clinical trial, OLYMPIA.

Arcutis Shares First Ever Research Revealing Gene Expression Profile of Seborrheic Dermatitis

The data was presented in a scientific session at the American Academy of Dermatology annual meeting.

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.

AnaptysBio Announces Positive Topline Results from Phase 3 Trial of Imsidolimab for GPP

Patients who responded to imsidolimab in GEMINI-1 and who moved into GEMINI-2 maintained clear or almost clear skin.

Expert Panel Confirms Efficacy and Safety of Roflumilast Topical Foam for Seborrheic Dermatitis Across Diverse Hair Types

They are confident prescribing roflumilast to patients with diverse skin and hair characteristics, including those with a history of hair treatments.

Crystal Structure of Bimekizumab Fab Fragment Supports Efficacy of IL-17 Dual Inhibition

Christopher Bunick, MD, PhD, provided insights into research exploring bimekizumab’s unique binding to IL-17F and IL-17A by analyzing crystals of bimekizumab fragment antigen-binding.

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.

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.

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

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

Market and Pharma News, Drug Watch

LEO Pharma Completes Key Asset Acquisition, Including TMB-001, From Timber Pharmaceuticals

The finalized acquisition came 5 months after Timber Pharmaceuticals filed for chapter 11 bankruptcy.

Roflumilast Foam, 0.3% for Seborrheic Dermatitis Launches in US

Zoryve was previously approved for the treatment of seborrheic dermatitis in patients ages 9 years and older.

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.

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.

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.

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.

Lindus Health and Acinonyx Bio to Partner in Clinical Trial Evaluating a Benzoyl Peroxide Alternative

Acinonyx Bio's topical cream, ACX, targets Propionibacterium acnes.

Upadacitinib Available for Pediatric Patients with pJIA, PsA

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

New Clinical Guidelines for Nonmelanoma Skin Cancer Published by Dermatology Association of Radiation Therapy

The guidelines for BCC and SCC treatment with IGSRT detail diagnosis, staging, contraindications, protocols, and emphasize the essential role of a multidisciplinary team.

Roflumilast Cream 0.15% for Atopic Dermatitis Now Commercially Available

Approved down to the age of 6, the treatment is covered by 2 pharmacy benefit manager contracts to provide timely coverage.

Apremilast Now Available for Pediatric Use in the US

The availability is notable as it introduces the first oral treatment option for young psoriasis patients.

Organon to Acquire Dermavant Sciences and Tapinarof Cream

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

Don’t miss a moment of Dermatology Times by signing up for our eNewsletters and subscribing to receive the free print issue and supplements each month.