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The U.S. Food and Drug Administration has approved Arcutis Biotherapeutics' Zoryve (roflumilast) topical foam 0.3% for the ...
The FDA approved a supplemental new drug application for roflumilast topical foam 0.3% for the treatment of plaque psoriasis ...
The 0.3% foam formulation of roflumilast was previously approved for the treatment of seborrheic dermatitis in adults and ...
The approval was supported by data from 2 randomized, double-blind, vehicle-controlled trials that included 736 patients aged 12 years and older with mild to severe plaque psoriasis of the scalp and ...
Icotrokinra led to high rates of skin clearance in patients with scalp and genital psoriasis, according to results from the ICONIC-TOTAL study.
Roflumilast foam 0.3% applied once daily led to significantly greater clearance of scalp and body plaque psoriasis lesions and more rapid itch reduction than placebo over eight weeks.
A total of 432 patients (56.3% women) aged 12 and older with psoriasis on the scalp and body were randomly assigned to two groups, one of which used roflumilast foam 0.3% once a day for eight ...
Roflumilast foam, 0.3%, proved to be a simplified treatment regimen with high efficacy for patients with scalp and body ...
Once-daily roflumilast foam, 0.3% (Zoryve) significantly improved scalp and body symptoms of plaque psoriasis in a phase III trial. Improvements in scalp itch were also greater for patients ...
Results showed 66% of patients treated with icotrokinra achieved an ss-IGA score of 0/1 and 77% achieved a sPGA-G score of 0/1, compared with 11% and 21% receiving placebo, respectively, at week 16.
66% of patients with scalp psoriasis achieved a scalp-specific Investigator's Global Assessment (ss-IGA) c score of 0/1 compared to 11% receiving placebo (P<0.001) at 16 weeks.