Arcutis presenta una sNDA para ZORYVE crema 0.05% en lactantes con dermatitis atópica

Arcutis presentó una sNDA a la FDA para ampliar la indicación de ZORYVE crema 0.05% a lactantes de 3 a 24 meses con dermatitis atópica leve a moderada. La solicitud añade un nuevo grupo de edad pediátrica a la etiqueta de dermatitis atópica del medicamento. Aún no se ha asignado ninguna fecha PDUFA.

Datos clave

Presentado: 6 may 2026, 20:03
Evento: Solicitud presentada
Dirección: Positivo
Empresa: ARQTArcutis
Activo: roflumilast
Fuente: SEC 8-K
Confianza: Con fuente

Extracto de la fuente

EX-99.1 2 pressreleaseex991q12026.htm EX-99.1 Document Arcutis Announces First Quarter 2026 Financial Results and Provides Business Update • Q1 2026 net product revenue for ZORYVE® (roflumilast) was $105.4 million, a 65% increase compared to Q1 2025, and a 17% decrease compared to Q4 2025 • Continued strong demand for ZORYVE despite typical Q1 seasonality, with continued growth in share of branded non-steroidal topical treatments • Submitted supplemental New Drug Application (sNDA) for ZORYVE cream 0.05% to the U.S. Food and Drug Administration (FDA) to expand the indication for the treatment of atopic dermatitis in infants ages 3 to 24 months • Completed enrollment in ZORYVE foam 0.3% Maximum Usage Systemic Exposure (MUSE) trial in children with plaque psoriasis of the scalp and body a

SEC 8-K