Zoryve filed with sNDA to FDA for plaque psoriasis in children ages 2 to 11
Arcutis Biotherapeutics announced the submission of a supplemental new drug application (sNDA) to the FDA for the expanded indication of Zoryve (roflumilast) cream 0.3% for the treatment of plaque psoriasis in children ages 2 to 11
As with adults and adolescents, plaque psoriasis is the most common form of psoriasis in children 2 to 11 years of age, with very similar clinical features.
Zoryve was approved by the FDA in July 2022 for the topical treatment of plaque psoriasis in adults and adolescents 12 years of age and older. Zoryve is a steroid-free, topical PDE4 inhibitor which effectively clears plaque psoriasis in both hard-to-treat areas such as knees and elbows, as well as sensitive areas such as the face, intertriginous areas, and genitalia.
The submission is based on data from two recently completed 4-week MUSE studies (NCT04655313 ; NCT04746911) in children aged 2 to 11 years with plaque psoriasis. Pharmacokinetic, safety, tolerability, and efficacy data from these two studies are consistent with data from the DERMIS-1 and DERMIS-2 pivotal Phase III trials. Arcutis worked with the FDA on the design of the MUSE studies, which are intended to fulfill FDA post-marketing requirements for Zoryve.
910 mins
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.