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Arcutis’s Zoryve Succeeds In Second Phase III In Atopic Dermatitis

 
• By Joseph Haas

Immuno-dermatology specialist intends to submit the topical roflumilast to the US FDA during the first half of 2023, potentially adding an even larger indication to its approval for psoriasis.

Atopic dermatitis
Arcutis moves toward adding AD to the Zoryve label • Source: Shutterstock

With success in a second Phase III trial of its topical formulation of roflumilast in atopic dermatitis, Arcutis Biotherapeutics, Inc. moved closer to seeking a supplemental approval of Zoryve (roflumilast) in AD, which analysts said would be an even bigger market opportunity than the drug’s initial indication in plaque psoriasis.

Arcutis obtained US Food and Drug Administration approval of the topical phosphodiesterase-4 (PDE4) inhibitor for plaque psoriasis in July and...

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Pipeline Watch: Seven Approvals And Five Phase III Readouts

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