Shots:
- The US FDA has accepted the sNDA of Zoryve (0.3% roflumilast cream) for the treatment of children (2-5yrs.) with PsO (PDUFA: Jun 29, 2026)
- The sNDA is supported by a 4wk. MUSE study in children (2-5yrs.) with PsO & a long-term open-label study showing consistent favorable safety, tolerability, & sustained efficacy across all age groups
- Zoryve is a topical formulation of the targeted PDE4 inhibitor roflumilast & is approved at 0.3% strength for treating PsO in pts (≥6yrs.)
Ref: Arcutis Biotherapeutics| Image: Arcutis Biotherapeutics| Press Release
Related News:- Arcutis Biotherapeutics Receives the US FDA’s Approval for Zoryve Topical Cream to Treat Atopic Dermatitis
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
