Dermatology Times March 2024 Recap

Clearances, Approvals, Updates, and Recommendations

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.

UCB Receives Positive CHMP Opinion for Bimekizumab for Moderate to Severe HS

If approved, bimekizumab will be the first IL-17A and IL-17F inhibitor approved in Europe for hidradenitis suppurativa.

Tunlametinib Wins Approval in China for NRAS+ Advanced Melanoma After PD-1/PD-L1 Therapy

China’s NMPA has approved tunlametinib for the treatment of patients with NRAS-mutated advanced melanoma after prior anti–PD-1/PD-L1 therapy.

BLAs and NDAs

FDA Accepts Journey Medical’s NDA for DFD-29 for Rosacea

The anticipated PDUFA date is November 4, 2024.

FDA Accepts Citius's Resubmitted BLA for Denileukin Diftitox for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma

The FDA has assigned a Prescription Drug User Fee Act target action date for August 13.

Big Studies and Big Data

BREAKING NEWS: 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.

Apogee Announces Positive Phase 1 Interim Data for APG777 in Atopic Dermatitis, Inflammatory Diseases

In addition to the announcement of positive data, Apogee said the trial has already exceeded its objectives ahead of schedule.

Zabalafin Hydrogel Significantly Improves Itch in Phase 2a Trial for AD

Alphyn’s first-in-class therapeutic is designed to treat the immune system component, and more specifically the bacterial component, of AD.

Late-Breaking Data: Upadacitinib for Vitiligo Achieves Skin Repigmentation Through Week 52

Iltefat Hamzavi, MD, reviews late-breaking data at AAD on upadacitinib as monotherapy.

Late-Breaking Data: Lutikizumab Shows Positive Results in Difficult-to-Treat HS After Failed TNF Therapy

Alexandra Kimball, MD, FAAD, reviews late-breaking data at AAD on lutikizumab for hidradenitis suppurativa.

Lawrence Eichenfield, MD: Outlining Late-Breaking INTEGUMENT-PED Data for Roflumilast in Pediatric Patients

Eichenfield discusses the late-breaking data on roflumilast cream 0.05% in the pediatric patient population and its implications.

Late-Breaking Data: Long-Term Safety and Efficacy of Delgocitinib Cream for Chronic Hand Eczema

Melinda Gooderham, MSc, MD, FRCPC, provided insights into the significance of the DELTA 3 extension data presented at AAD 2024.

Late-Breaking Data: 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.

Late-Breaking Phase 2b Data Showed Efficacy of Injectable Polidocanol for Submental Fat Reduction

The injectable polidocanol exhibited high efficacy, quicker onset of benefit, reduced downtime, and fewer side effects lasting longer than 30 days.

Late-Breaking Data: Povorcitinib Significantly Improves Itch and Lesions in Prurigo Nodularis

Shawn Kwatra, MD, shares positive updates on phase 2 oral povorcitinib for prurigo nodularis at AAD 2024.

Phase 2b/3 Trial of Izokibep Meets Primary Endpoints for Psoriatic Arthritis, According to Positive Top-line Results

Acelyrin announced the positive results, of which the primary endpoint was met with high statistical significance, earlier this week.

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.

Market and Pharma News, Drug Watch

An Inside Look in the Development of CGB-500 For Atopic Dermatitis Treatment

Nitin Joshi, PhD, shared CAGE Bio’s development of CGB-500 and why phase 2 EASI scores have the company’s scientific advisory board optimistic.

Nektar Announces Initiation of Phase 2b Study for Rezpegaldesleukin in Severe, Very Severe Alopecia

The study will evaluate rezpegaldesleukin and its effect on Severity of Alopecia Tool scoring by the conclusion of a 36-week period.

Strides for Skin Health Equity

Celebrating Women in Dermatology

Today is International Women's Day. Dermatology Times spoke with 5 women clinicians in the field to discuss the influences and advice that brought them to where they are today.

Tapinarof Cream 1% Efficacious in Adults and Children With Skin of Color Down to 2 Years With AD

New data was presented at the American Academy of Dermatology Annual Meeting in San Diego, California.

Nicole A. Negbenebor, MD: Uplifting Women Clinicians

In celebration of Women's History Month and today, which is International Women's Day, dermatologist Nicole Negbenebor, MD, discusses her journey in the dermatology space and provides advice for young women and girls aspiring to enter the medical field.

American Academy of Dermatology Upholds Diversity Policies in Face of Anti-DEI Proposal

A vote during the annual meeting will keep DEI initiatives in place and members are awaiting news on what those initiatives will look like.

Advocating for Increased Representation of Women in Dermatology

The Bristol Myers Squibb-hosted event brought together a panel of leading women in dermatology to discuss the challenges they’ve faced and how women can support each other.

Women's Dermatologic Society: New President Shares Hopes for Enduring Positive Change on Organization and Dermatology

Dermatology Times recently spoke with Latanya Benjamin, MD, FAAD, FAAP, the newly-appointed president of the WDS, to discuss her hopes and goals for her presidency.

Amy Spizuoco, DO, FAOCD: Addressing STDs and Utilizing Dermatopathology With Care in Diverse Patient Populations

Spizuoco shares pearls from her sessions, "Infectious Diseases: The Story Behind STDs," and "Everything You Need to Know About Dermatopathology and the Dermatopathologist," from the Diversity in Dermatology conference.

A Spotlight on SCIN: A New Tool From Google and Researchers at Stanford Medicine

Researchers from Google and Stanford Medicine recently partnered to develop the Skin Condition Image Network dataset, a tool aimed at providing image resources for conditions across skin tones.

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