FDA nod for only topical PDE4 inhibitor for plaque psoriasis
The US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Zoryve (roflumilast) cream 0.3% for the treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age or older, the drug’s developer, Arcutis Biotherapeutics (Nasdaq: ARQT), announced on Friday, when is shares closed up 3.8% at $24.26.
The first and only topical phosphodiesterase-4 (PDE4) inhibitor approved for the treatment of plaque psoriasis, Zoryve provides rapid clearance of psoriasis plaques and reduces itch in all affected areas of the body. Zoryve - a once-daily, steroid-free cream in a safe and well tolerated, patient-friendly formulation - is uniquely formulated to simplify disease management for people living with plaque psoriasis, said the California, USA-based in immuno-dermatology products developer.
To be made available by mid-August
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