FDA accepts sNDA for Arcutis’ Zoryve

The US Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Zoryve (roflumilast) cream 0.05% to expand the indication for the topical treatment of mild to moderate atopic dermatitis to include infants aged 3 to 24 months, said Arcutis Biotherapeutics (Nasdaq: ARQT), whose shares closed up 3% at $28.50 following the announcement yesterday.

The FDA has set a PDUFA target action date of February 23, 2027, the California, USA-based immune-dermatology focused biopharma company noted.