Verrica Pharmaceuticals Announces Receipt of Minutes from Type C Meeting with FDA Regarding Clinical Development of YCANTH™ for the Treatment of Common Warts
Retrieved on:
Thursday, January 4, 2024
More specifically, the Company believes that the Type C meeting satisfied its objective to gain the FDA’s advice and agreement on the overall design of a pivotal Phase 3 study of YCANTH that would support an efficacy supplement for the proposed indication of common warts.
Key Points:
- More specifically, the Company believes that the Type C meeting satisfied its objective to gain the FDA’s advice and agreement on the overall design of a pivotal Phase 3 study of YCANTH that would support an efficacy supplement for the proposed indication of common warts.
- YCANTH is currently only approved to treat molluscum contagiosum in adults and children two years of age and older.
- “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 & Chief Executive Officer of Verrica Pharmaceuticals.
- 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.”