The US Food and Drug Administration (FDA) announced today its approval of Ligand Pharmaceuticals Incorporated's berdazimer gel, 10.3% for the treatment of molluscum contagiosum in patients ages 6 months and older.1
This approval makes berdazimer gel only the second FDA-approved treatment for this indication, following the approval of Verrica Pharmaceutical's Ycanth (formerly VP-102) in July of last year.
The approval of [berdazimer gel] Zelsuvmi is a breakthrough, marking the first time that clinicians can treat molluscum with an efficacious topical prescription medication that is applied by the patient, or a family member, said Mark D. Kaufmann, MD, FAAD, clinical professor of Dermatology in the department of dermatology at the Icahn School of Medicine at Mount Sinai in New York, New York and past president of the American Academy of Dermatology, in a press release. I look forward to having this novel medication to treat my molluscum patients.
The approval comes just under a year after the FDA accepted its New Drug Application (NDA) for berdazimer in March of 2023.2
The NDA and approval are based on positive data stemming from the B-SIMPLE4 (NCT04535531) trial, published in the Journal of the American Medical Association Dermatology.3
In the phase 3 study, berdazimer gel demonstrated statistically significant improvements in the clearance of treatable molluscum contagiosum at week 12.
Additionally, berdazimer gel was well-tolerated among patients, with the most common adverse events reported as being mild application site pain and mild-to-moderate erythema.
Key outcomes of the study also included a lesion count of 0 or 1 of all treatable molluscum contagiosum at week 12, a 90% reduction from baseline in the number of all treatable molluscum contagiosum at week 12, complete clearance of all treatable molluscum contagiosum at week 8, and a change from baseline in the number of all treatable molluscum contagiosum at week 4.
The approval of berdazimer gel, 10.3% marks a significant milestone in the treatment of this burdensome, highly contagious condition.
Authors of the B-SIMPLE4 study wrote, "Molluscum contagiosum infection is usually self-limited, yet may persist for months to years, generating a substantial health care burden and quality-of-life concerns necessitating therapeutic intervention.Treatment may also be warranted because of its highly contagious nature and concern for infecting peers or household members.Additionally, outwardly visible lesions may be associated with discomfort and psychosocial stigma, and may scar after resolution.
References
Read more here:
FDA Approves Berdazimer Gel, 10.3% for the Treatment of Molluscum Contagiosum - Dermatology Times
- Advancing Hidradenitis Suppurativa Care - Early Diagnosis, Biologic Therapies, and Multidisciplinary Approaches: Part 3 - Dermatology Times - March 30th, 2025 [March 30th, 2025]
- Top 5 Articles of the Month: March - Dermatology Times - March 30th, 2025 [March 30th, 2025]
- Talking to Patients on Sunscreen Application and the Effects of Visible Light - Dermatology Times - March 30th, 2025 [March 30th, 2025]
- Challenges and Unmet Needs in Treating Pediatric Atopic Dermatitis - Dermatology Times - March 30th, 2025 [March 30th, 2025]
- Clinical Experience and Diagnosis of GPP - Dermatology Times - March 30th, 2025 [March 30th, 2025]
- Gene Expression Profiling and Other Molecular Tests Utilized for Melanoma and Squamous Cell Carcinoma - Dermatology Times - March 30th, 2025 [March 30th, 2025]
- Fixed-Dose Acne Treatment Gel is Safe and Effective for Hispanic Patients, According to Post-Hoc Analysis - Dermatology Times - March 30th, 2025 [March 30th, 2025]
- CBD and CBG Ointment Improved Skin in Patients with Atopic Dermatitis - Dermatology Times - March 30th, 2025 [March 30th, 2025]
- Utilizing Gene Expression Profiling to Avoid Unnecessary Interventions in a 72-Year-Old Woman With Melanoma - Dermatology Times - March 30th, 2025 [March 30th, 2025]
- Hims & Hers shutters Apostrophe in favor of its own tele-dermatology offerings - Fierce healthcare - March 15th, 2025 [March 15th, 2025]
- Closing Out AAD With Dermatology Times Editor in Chief - Dermatology Times - March 15th, 2025 [March 15th, 2025]
- Improving Patient Care in Dermatology Through Data, Innovation, Advocacy: AAD 2025 Recap - AJMC.com Managed Markets Network - March 15th, 2025 [March 15th, 2025]
- Inflammatory Arthropathy Risk Increased in Patients With Hidradenitis Suppurativa - Dermatology Advisor - March 15th, 2025 [March 15th, 2025]
- Expert Perspectives: Dermatology's Top Story to Watch in 2025 - MD Magazine - March 15th, 2025 [March 15th, 2025]
- Whats New in Dermatology for Pigmentary Disorders, with Andrew Alexis, MD, MPH - MD Magazine - March 15th, 2025 [March 15th, 2025]
- Home Phototherapy Proves Effective and Preferred in LITE Study for Psoriasis Treatment - Dermatology Times - March 15th, 2025 [March 15th, 2025]
- Efficacy, Safety, and Role in Therapy of JAK Inhibitors for Atopic Dermatitis - Dermatology Times - March 15th, 2025 [March 15th, 2025]
- Reviving the Classics: The Role of Older Medications in Modern Dermatology - AJMC.com Managed Markets Network - March 15th, 2025 [March 15th, 2025]
- Dermatology Therapeutics: Updates for Primary Care from AAD 2025 - Patient Care Online - March 15th, 2025 [March 15th, 2025]
- Advances in Dermatology Therapeutics: Key Insights from AAD 2025 - Patient Care Online - March 15th, 2025 [March 15th, 2025]
- The Impact of JAK Selectivity in Atopic Dermatitis Treatment - Dermatology Times - March 15th, 2025 [March 15th, 2025]
- Social Drivers of Health Success Stories in Dermatology | AAD 2025 - Managed Healthcare Executive - March 15th, 2025 [March 15th, 2025]
- Improving Acne Treatment Through Antibiotic Stewardship and Gut-Skin Health - Dermatology Times - March 15th, 2025 [March 15th, 2025]
- Advancing Recognition and Treatment of Allergic Contact Dermatitis - Dermatology Times - March 15th, 2025 [March 15th, 2025]
- Lebrikizumab Shows 3-Year Sustained Efficacy in AD - Dermatology Times - March 15th, 2025 [March 15th, 2025]
- AAD 2025: Galderma to Present Extensive Updates From Across Its Dermatology Portfolio, Demonstrating Its Category Leadership and Strong Momentum -... - March 5th, 2025 [March 5th, 2025]
- What to Look Forward to at the American Academy of Dermatology Annual Meeting 2025 - MD Magazine - March 5th, 2025 [March 5th, 2025]
- Recognizing the Achievements of Women in Dermatology - Dermatology Times - March 5th, 2025 [March 5th, 2025]
- The Solar Spectrum and Impact on Skin Health - Dermatology Times - March 5th, 2025 [March 5th, 2025]
- The Undetectable Era: How Patients Are Shifting Towards More Natural-Looking Results at the Clinic - Dermatology Times - March 5th, 2025 [March 5th, 2025]
- Researchers overseas: Radiology has become indispensable to dermatology - Radiology Business - March 5th, 2025 [March 5th, 2025]
- Defining Alopecia Areata Severity and Navigating Treatment Options - Dermatology Times - March 5th, 2025 [March 5th, 2025]
- Acne and TikTok: What Do Dermatologists Need to Know? - Dermatology Times - March 5th, 2025 [March 5th, 2025]
- Celebrating Womens History Month with Mindy Haws, MD, and the LIMITLESS Initiative - Dermatology Times - March 5th, 2025 [March 5th, 2025]
- A Case-Based Approach to Topical and Nonsteroidal AD Management - Dermatology Times - March 5th, 2025 [March 5th, 2025]
- Dermatology Partners Opens State-of-the-Art Dermatopathology Laboratory - citybiz - February 25th, 2025 [February 25th, 2025]
- Ethical Considerations and Guidance of Cosmeceuticals in Pediatric Care - Dermatology Times - February 25th, 2025 [February 25th, 2025]
- AI in Dermatology: Emerging Insights and Diverging Perspectives - MD Magazine - February 25th, 2025 [February 25th, 2025]
- Almirall 2024 Full-Year Results: Almirall Surpassed Guidance for 2024 - Entering an Era of Sustained Growth and Further Advancing Its Medical... - February 25th, 2025 [February 25th, 2025]
- Aesthetic Treatments: More Than Just Enhancements, A Path to Empowerment - Dermatology Times - February 25th, 2025 [February 25th, 2025]
- Samitivej to advance dermatology and aesthetic medicine in new partnership - Healthcare Asia - February 25th, 2025 [February 25th, 2025]
- Arcutis Announces Publication of Positive Data from INTEGUMENT-PED Trial Evaluating ZORYVE (roflumilast) Cream 0.05% in Children 2 to 5 Years Old with... - February 25th, 2025 [February 25th, 2025]
- U.S. Dermatology Partners Ranked the No. 1 Dermatology Group in the Nation by Castle Connolly - PR Newswire - February 3rd, 2025 [February 3rd, 2025]
- Alopecia Areata Risk May be Associated With Serum Vitamin D and Zinc Levels - Dermatology Advisor - February 3rd, 2025 [February 3rd, 2025]
- Age at Melanoma Diagnosis Varies by Sex, Anatomic Site, and Tumor Thickness - Dermatology Advisor - February 3rd, 2025 [February 3rd, 2025]
- Dermatology Medications and Solutions Market Poised to Growth USD 51.7 Billion by 2032 with Thriving CAGR of - EIN News - January 23rd, 2025 [January 23rd, 2025]
- Optimizing Care for Patients with Urticaria - Dermatology Times - January 23rd, 2025 [January 23rd, 2025]
- Advancing Care With Laser and Light-Based Technology in Dermatology - Dermatology Times - January 23rd, 2025 [January 23rd, 2025]
- Online Dermatology Consultation Market: CAGR of 15.4% Expected by 2025 Due to Increasing Skin Health Awareness - openPR - January 23rd, 2025 [January 23rd, 2025]
- VP-315 Demonstrates Positive Topline Results in Basal Cell Carcinoma - Dermatology Times - January 23rd, 2025 [January 23rd, 2025]
- AI and the Future of Cosmetic Dermatology: Experts Weigh in - Medscape - January 23rd, 2025 [January 23rd, 2025]
- When and How to Employ the Buy and Bill Model - Dermatology Times - January 23rd, 2025 [January 23rd, 2025]
- Innovating Scalp Care: How Research and Education Drive Solutions - Dermatology Times - January 15th, 2025 [January 15th, 2025]
- Rare Overlap of 2 Autoinflammatory Keratinization Diseases Observed in Single Lesion - Dermatology Times - January 15th, 2025 [January 15th, 2025]
- Expanding Laser Benefits for Diverse Patient Populations - Dermatology Times - January 15th, 2025 [January 15th, 2025]
- LEO Pharma and Gilead Will Develop STAT6 Program for AD and Other Inflammatory Diseases - Dermatology Times - January 15th, 2025 [January 15th, 2025]
- Kwon Min-ah, a former member of the group AOA, became the head of the dermatology consultation offic.. - - January 15th, 2025 [January 15th, 2025]
- Top 5 Dermatology Articles of 2024 - Managed Healthcare Executive - January 1st, 2025 [January 1st, 2025]
- DEI programs, sun safety: Read this years top practice management articles in dermatology - Healio - January 1st, 2025 [January 1st, 2025]
- Cutaneous Connection 2024: Top Dermatology Podcast Episodes and Insights of the Year - Dermatology Times - January 1st, 2025 [January 1st, 2025]
- Top Insights and Highlights from Dermatology Times' Interview Intersection: 2024 - Dermatology Times - January 1st, 2025 [January 1st, 2025]
- Providing Support for Comorbidities and Psychological Health in Patients with Atopic Dermatitis - Dermatology Times - January 1st, 2025 [January 1st, 2025]
- Reviewing Major Dermatologic Studies of the Year: 2024 - Dermatology Times - January 1st, 2025 [January 1st, 2025]
- Peak Dermatology in Visalia hopes to provide more skin services and treatment to the area - KFSN-TV - December 23rd, 2024 [December 23rd, 2024]
- Krystal Tawney of Pinnacle Dermatology celebrates 10 years of business in the Greenbrier Valley - Real WV - December 23rd, 2024 [December 23rd, 2024]
- Supporting Pediatric Patients With AD and Their Caregivers - Dermatology Times - December 23rd, 2024 [December 23rd, 2024]
- Photodynamic Therapy is an Effective, Long-Term Treatment for Actinic Keratosis - Dermatology Times - December 23rd, 2024 [December 23rd, 2024]
- InflaRx Advances INF904 for CSU and HS with Phase 2a Study - Dermatology Times - December 23rd, 2024 [December 23rd, 2024]
- Advanced Dermatology to pay $15G fine after doctor refused to perform procedure on HIV-infected patient - Newsday - December 9th, 2024 [December 9th, 2024]
- Efficacy of Combining Postbiotic Formulation with Microneedling for Acne - Dermatology Times - December 9th, 2024 [December 9th, 2024]
- Burden of Hidradenitis Suppurativa on Patients and Diagnostic Challenges - Dermatology Times - December 9th, 2024 [December 9th, 2024]
- Opioid-Prescribing Trends in Dermatology From 2014 to 2020 in the United States - Cureus - November 28th, 2024 [November 28th, 2024]
- Amid challenges, the Baton Rouge dermatology industry is evolving - Greater Baton Rouge Business Report - November 28th, 2024 [November 28th, 2024]
- Polynucleotide Therapy Shows Promise in Scar and Burn Management - Dermatology Times - November 28th, 2024 [November 28th, 2024]
- Revolutionizing Dermatology: How Emerging Technologies are Shaping the Future of Skin Care - Spherical Insights - November 28th, 2024 [November 28th, 2024]
- Dermatology OTC Medications Market Size, Scope Analysis, Key Insights, Leading Key Players, And Forecast To 2033 - openPR - November 28th, 2024 [November 28th, 2024]
- Jeff Stark, MD: Insights on the Approval of Bimekizumab for HS - Dermatology Times - November 28th, 2024 [November 28th, 2024]
- Exploring the Atopic Dermatitis Treatment Paradigm and Challenging Cases: Part 2 - Dermatology Times - November 28th, 2024 [November 28th, 2024]
- Patient Education and Novel Topical Therapies for AD - Dermatology Times - November 28th, 2024 [November 28th, 2024]
- TikTok dermfluencers have medical students flocking to dermatology, where they can make half a million dollars a year and work four days a week -... - November 20th, 2024 [November 20th, 2024]