Arcutis Reports the US FDA Acceptance of NDA for Roflumilast to Treat Seborrheic Dermatitis in Individuals Aged ≥9 Years
Shots:
- The US FDA has accepted the NDA for review of roflumilast (0.3%) to treat patients aged ≥9yrs. with SD The US FDA’s decision is expected on Dec 2023
- The NDA was based on the P-II trial & P-III trial (STRATUM) evaluating roflumilast vs vehicle. The P-III study met its 1EPs with an IGA success rate of (79.5% vs 58.0%) @8wk., an improvement on IGA Success at 2wk. & complete clearance (51.3%) @8wk.
- Improvement on all 2EPs incl. itch, scaling & erythema, ≥60% achieved an itch response @8wk. (62.8% vs 40.6%), improvements in itch @2 & 4wk., was well-tolerated with a favorable safety & tolerability profile. In the combined P-II & III studies, ~ 90% completed the full 8wks. of treatment, AEs leading to treatment discontinuation (0.9% vs 2.2%, respectively)
Ref: Arcutis | Image: Arcutis
Related Post:- Arcutis Reports the NDA Submission of Roflumilast to the US FDA for the Treatment of Seborrheic Dermatitis
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