Arcutis Reports the Health Canada Acceptance of New Drug Submission for Review of Roflumilast to Treat Plaque Psoriasis

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The NDS submission was based on the P-III program & two P-III (DERMIS-1 & 2) OLE studies to evaluate roflumilast (0.3%) vs vehicle in patients with PsO. The US FDA’s action date is April 2023
Both the trial met their 1EPs & showed an IGA success rate of (42.4% vs 6.1%) and (37.5% vs 6.9%) in (DERMIS-1 & 2) trial, a significant improvement on 2EPs incl. on I-IGA Success, PASI-75, reductions in itch as measured by WI-NRS, and patient perceptions of symptoms. Efficacy results from the OLE study were maintained throughout treatment @6 & 12mos., was generally well-tolerated with a favorable safety and tolerability profile
Roflumilast’s NDA is also under US FDA’s review for the treatment of PsO in adolescents and adults with an expected US FDA decision on July 29, 202

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