Arcutis Enjoys Seborrheic Dermatitis Win But Experts Itching For Psoriasis Approval

The firm is planning a US NDA filing after its roflumilast formulation succeeded in a pivotal seborrheic dermatitis study but analysts are keener on a ‘make or break’ approval in psoriasis.  

Roflumilast Has An Oral, Cream And Foam Formulation • Source: Shutterstock

Arcutis Biotherapeutics, Inc.’ roflumilast foam product has passed an advanced seborrheic dermatitis study prompting filing plans but experts are more invested in a potentially “transformational” psoriasis approval expected in July.

The Westlake Village, CA-headquartered biotech unveiled topline data from the Phase III STRATUM study of 457 seborrheic dermatitis patients on 6 June. Roflumilast foam 0.3% met the primary endpoint with...

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