Arcutis Reports the Health Canada Acceptance of New Drug Submission for Review of Roflumilast to Treat Plaque Psoriasis
Shots:
- 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
Ref: Globenewswire | Image: Arcutis
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