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Arcutis Biotherapeutics submits NDA to U.S. FDA for roflumilast foam 0.3%
The Fly

Arcutis Biotherapeutics submits NDA to U.S. FDA for roflumilast foam 0.3%

Arcutis Biotherapeutics announced the submission of a New Drug Application, NDA, to the U.S. Food and Drug Administration for roflumilast foam 0.3% for the treatment of moderate to severe seborrheic dermatitis in adults and adolescents. "Seborrheic dermatitis can be particularly difficult to treat as it primarily presents on the face and hair-bearing areas of the body such as the scalp, and often requires individuals to use multiple treatments. Arcutis recognizes the urgent need for a new therapy that could enable symptom control, easier management, and increased adherence," said Patrick Burnett M.D., Ph.D, F.A.A.D., Chief Medical Officer at Arcutis. "Roflumilast foam, which is being developed as an easy-to-use, steroid free, once-daily topical treatment, has been shown in clinical trials to be effective and well tolerated. If approved, roflumilast foam has the potential to become the new standard of care for those living with seborrheic dermatitis." The submission is supported by positive results from Arcutis’ pivotal Phase 3 trial. The STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis was a Phase 3, parallel group, double blind, vehicle-controlled study evaluating the safety and efficacy of roflumilast foam 0.3%. Roflumilast met its primary endpoint with an ‘IGA Success’ rate of 79.5% compared to a vehicle rate of 58.0% at Week 8.

Published first on TheFly

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