Insights+: The US FDA New Drug Approvals in January 2024

Shots: 

• The US FDA approved 1 NDA in January 2024, leading to treatments for patients and advances in the healthcare industry 
• In January 2023, Zelsuvmi was approved by the US FDA for the Treatment of Molluscum Contagiosum 
• PharmaShots has compiled a list of US FDA-approved drugs in the month January 2024 

1. Ligand Pharmaceuticals’ Zelsuvmi Receives the US FDA’s Approval for the Treatment of Molluscum Contagiosum 

    Active Ingredient: Berdazimer Topical Gel 

    Approved: Jan 8, 2024 

    Company: Ligand Pharmaceuticals                         

    Disease: Molluscum Contagiosum  

• Zelsuvmi (berdazimer topical gel, 10.3%) received the US FDA’s approval as a novel drug for the treatment of molluscum infections in adults & pediatric patients aged ≥1yrs. Zelsuvmi is expected to be commercially available in the US by H2’24 
• The company evaluated the safety & effectiveness of the US FDA-approved Zelsuvmi in P-III clinical trials (B-SIMPLE 4) & (B-SIMPLE 2) among patients (n=1,598) with Molluscum Contagiosum that depicted Zelsuvmi’s ability to reduce lesion counts & was well tolerated as QD dosage in patients 
• Zelsuvmi is a nitric oxide (NO) releasing agent that has been attributed to have antiviral properties. With an unknown mechanism of action Zelsuvmi will be used as a topical treatment in patients above the age of 1year (pediatric & adults) 

Note:  

• According to the FDA’s January 2024 approval list, the combination therapy of Dolutegravir, Emtricitabine, Tenofovir, and Alafenamide was also approved; however, no PR was available 

Related Post: Insights+: The US FDA New Drug Approvals in December 2023