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 unknown mechanism of action of Zelsuvmi will be used as a tropical treatment in patients above 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
Zelsuvmi, Ligand Therapeutics, US FDA, Approval, NDA, BLA, Biologics, Combination Therapy, Dolutegravir, Emtricitabine, Tenofovir, Alafenamide, Molluscum Contagiosum,
