The Type C meeting held this past December involved discussion of a phase 3 clinical development plan for Ycanth in the treatment of common warts.
Verrica Pharmaceuticals announced today the receipt of meeting minutes from its Type C meeting with the US Food and Drug Administration (FDA) to discuss the phase 3 clinical development of Ycanth (formerly VP-102) for common warts.
Currently, Ycanth is approved by the FDA only for the treatment of molluscum contagiosum in children and adults as young as 2 years of age and older.
Ycanth has already successfully undergone the completion of a phase 2 study for the treatment of common warts, as well as a separate phase 2 study for the indication of external genital warts.
Read more from Dermatology Times on the approval of Ycanth for molluscum contagiosum here.
Verrica reported that it met with the FDA on November 6 to discuss the clinical development plan of the drug for this indication.
Both Verrica and the FDA solidified an agreement on the design of a pivotal phase 3 study. The study design would support an efficacy supplement for the common wart indication.
“We believe our recent Type C meeting with the FDA was highly productive and led to mutual alignment with respect to the design of a Phase 3 development plan to evaluate YCANTH for the treatment of common warts,” said Ted White, president and chief executive officer of Verrica, in a press release.
“Based upon positive results from our Phase 2 studies, we consider YCANTH to have significant potential to address this sizable market opportunity which affects over 20 million people in the US annually with no FDA approved products," White said. "We remain focused on addressing some of the largest unmet needs in dermatology, and the successful outcome of this Type C meeting is an important step forward as we evaluate label expansion opportunities for YCANTH.”
BioSpace. Verrica Pharmaceuticals announces receipt of minutes from type C meeting with FDA regarding clinical development of YCANTH for the treatment of common warts. BioSpace. January 4, 2024. Accessed January 4, 2024. https://www.biospace.com/article/releases/verrica-pharmaceuticals-announces-receipt-of-minutes-from-type-c-meeting-with-fda-regarding-clinical-development-of-ycanth-for-the-treatment-of-common-warts/