FDA approval of Zelsuvmi Berdazimer 10 3 topical gel for the treatment of molluscum contagiosum

Mondo Health Updated on 2024-01-31

With the continuous development of science and technology, the field of drug research and development has ushered in many innovative solutions. Ligand Pharmaceuticals recently announced that its leading "first-in-class" drug, Zelsuvmi (Berdazimer, 103%) Topical gel has been approved by the US FDA for molluscum contagiosum (molluscum) in children 1 year of age and older. This result will provide a new option for patients with infectious infections.

The efficacy of zelsuvmi was well validated in two pivotal phase 3 trials (b-**4 and b-**2). In the B-**4 trial, the investigators evaluated the safety and efficacy of molluscum berdazimer** with encouraging results. After 12 weeks**, the patient achieved complete clearance of molluscum lesions, a statistically significant improvement (p<0.).001)。

The Phase 3 B-** clinical program covered a total of 1,598 patients, and the analysis showed that Zelsuvmi was well tolerated at the once-daily dosing frequency. In clinical trials, topical site reactions are one of the most common adverse reactions, but their incidence is only more than 1%.

zelsuvmi(berdazimer,10.3%) Topical gel is a new chemical entity (NCE) that has the ability to release nitric oxide (NO) and has antiviral activity. However, the exact mechanism of action of molluscum contagiosum is still unknown. This unique drug is the first and only topical prescription drug that provides a new topical prescription drug for this highly contagious viral infection.

Zelsuvmi is unique in that it became the first topical prescription drug that can be used at home, outside the doctor's office, or in other medical settings. This provides a more convenient and flexible option for patients, parents or caregivers to better manage this highly contagious viral infection.

Molluscum contagiosum is a common** infection caused by a virus. The infection causes round, hard** bumps that vary in size from the size of a needle to an eraser. If the lump is scratched or injured, the infection may spread to the nearest **. In addition, molluscum contagiosum can be spread through person-to-person contact as well as contact with infected objects. Although this infection is common in children, adults, especially those who are immunocompromised, can also be infected.

The approval of Zelsuvmi topical gel provides a new** option for people with molluscum contagiosum. By releasing nitric oxide, the drug exhibits antiviral activity, making it an innovative topical prescription drug for highly contagious viral infections. Patients and medical professionals can easily use it in a variety of settings, providing more flexibility for management and **. With the launch of this innovative protocol, we look forward to further progress in the field of infection in the future."

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