WEST CHESTER, PA — Verrica Pharmaceuticals Inc. (Nasdaq: VRCA) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has provided positive feedback supporting the company’s plan to file a Marketing Authorization Application (MAA) for YCANTH®, its treatment for molluscum contagiosum.
The feedback marks a major step toward potential European approval of YCANTH, which would make it the first FDA-approved therapy for molluscum contagiosum to enter the European market. The CHMP’s written guidance confirmed that Verrica’s existing clinical and safety data from previously completed Phase 3 studies in the U.S. and Japan are sufficient to support an application, and that no additional Phase 3 trials are required.
“We are pleased to gain alignment with CHMP with respect to the safety and efficacy data requirements to support an MAA filing for YCANTH in the European Union,” said Jayson Rieger, PhD, MBA, President and Chief Executive Officer of Verrica. “Based on convincing efficacy data from the well-controlled Phase 3 studies successfully conducted in both the U.S. and Japan, the CHMP concluded that no further Phase 3 clinical studies are needed in order to progress toward a filing for approval. The European market for molluscum represents a significant unmet need for millions of potential patients, and this feedback provides Verrica with a key catalyst to explore a broad range of strategic opportunities for realizing the full commercial potential of YCANTH and to treat patients with molluscum in this large and underserved market.”
Verrica’s consultation with the CHMP addressed several critical elements of the potential submission, including the design of the prior Phase 3 trials, duration and endpoints, patient population, and safety and nonclinical data packages. The agency also confirmed that existing nonclinical studies and published literature are sufficient to support the company’s planned filing.
The feedback provides a clear regulatory path forward for YCANTH in Europe, where molluscum contagiosum—a common viral skin infection affecting millions, particularly children—currently lacks approved pharmaceutical treatments. Verrica’s positive engagement with the CHMP positions the company to advance toward submission of its MAA and explore future strategic partnerships aimed at commercialization in the region.
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