A Phase 2b, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Adolescents and Adults With Scalp and Body Psoriasis
Latest Information Update: 10 Nov 2024
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At a glance
- Drugs Roflumilast (Primary)
- Indications Plaque psoriasis
- Focus Therapeutic Use
- Sponsors Arcutis Biotherapeutics
- 06 Nov 2024 According to an Arcutis Biotherapeutics media release, submitted sNDA for ZORYVE foam for scalp and body psoriasis to the FDA based on the positive results from the pivotal ARRECTOR Phase 3 trial and a Phase 2b trial, was accepted by the FDA in September with a PDUFA action date set for May 22, 2025.
- 23 Jul 2024 According to an Arcutis Biotherapeutics media release, the company announced submission of a supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) foam 0.3%, a once-daily,for the treatment of adults and adolescents ages 12 and over with scalp and body psoriasis.
- 05 Jun 2023 Results published in the British Journal of Dermatology