FDA approves ZELSUVMI™, a novel drug for the treatment of Molluscum Contagiosum
Type of article: News
MedED Catalogue Reference: MNDD001
Category: Novel Drugs & Emergent Therapeutics | Dermatology
Keywords: Molluscum contagiosum, dermatology, DNA poxvirus, skin dermatosis, HIV, paediatrics, viral skin infection
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5th of December 2024
The U.S. Food and Drug Administration (FDA) has approved ZELSUVMI™ (berdazimer gel, 10.3%), the first treatment for the highly contagious skin infection Molluscum contagiosum (molluscum).
Caused by a DNA poxvirus of the same name, Molluscum contagiosum is transmitted through contact with an infected person or object. While it occurs most frequently in children and young adults, the condition does affect adults, where infection most often occurs via sexual transmission. HIV patients and immunocompromised patients are particularly vulnerable to infection, and the condition in these patients is challenging to treat. 1
Molluscum presents as raised red or skin-coloured bumps with a central, umbilicated viral core. Patients may present with over a hundred lesions in the most severe cases. The condition will resolve spontaneously, but it is not unusual for infections to persist for 13 months to 5 years. Complications include secondary infections and keloid or hypertrophic scar development. 3
Learn More
Chen, X., Anstey, A. V., & Bugert, J. J. (2013). Molluscum contagiosum virus infection. The Lancet. Infectious diseases, 13(10), 877–888. https://doi.org/10.1016/S1473-3099(13)70109-9
ZELSUVMI™ is a topical gel whose active ingredient is a nitric oxide-releasing agent. The exact mechanism of action is unknown, but in clinical trials ( B-SIMPLE 4 and B-SIMPLE 2 and phase 3 trial B-Simple 3 ) the drug significantly reduced the lesion count in affected patients with relatively few adverse reactions (≥1%). The most common side effects were mild application-site pain and erythema.2
According to the manufacturer Ligand Pharmaceutical Incorporate, the B-Simple trials represented the most extensive global clinical program in molluscum to date, shining a light on this often neglected condition.1
ZELSUVMI™was approved for use in adults and paediatric patients older than one year and is expected to be available in the United States in the second half of 2024.
Clinical Trial Registration Number: NCT04535531
ClinicalTrials.gov A Phase 3 Molluscum Contagiosum Efficacy and Safety Study (B-SIMPLE4)
Access associated content
2. Press Release: U.S. Food and Drug Administration Approves ZELSUVMI™ as a First-in-Class Medication for the Treatment of Molluscum Contagiosum
3. Press Release: Novan Announces Publication of Positive Results from Pivotal Phase 3 Study of Berdazimer Gel, 10.3% (SB206) in Patients with Molluscum Contagiosum in JAMA Dermatology
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