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Arcutis Biotherapeutics, Inc has submitted a supplemental New Drug Application for roflumilast cream (ZORYVE) to the US Food and Drug Administration for treatment of plaque psoriasis in children aged 2 to 11 years.
Arcutis Biotherapeutics, Inc has submitted a supplemental New Drug Application of roflumilast cream 0.3% (ZORYVE; Arcutis Biotherapeutics, Inc) for treatmentof plaque psoriasis in pediatric patients aged 2 to 11 years.
The submission is backed by 4-week Maximal Usage Systemic Exposure (MUSE) studies in children aged 2 to 11 years with plaque psoriasis. Study results demonstrated positive safety and efficacy data, matching results from the DERMIS-1 and DERMIS-2 phase 3 trials. The MUSE studies were made to match US Food and Drug Administration (FDA) post-marketing requirements forroflumilast cream.
The FDA approved ZORYVE in July 2022 as a topical treatment against plaque in patients aged 12 years and older. Trials and clinical use of roflumilast cream have shown safety and tolerance, with minimal local site reactions.
Roflumilast cream is a moisturizing cream that does not include sensitizing excipients or irritants. If approved, it will be the first steroid-free topical phosphodiesterase-4 inhibitor used in children with plaque psoriasis. It can be used in areas commonly difficult to treat such as knees and elbows, or that are sensitive such as face, genitalia, and skin folds.
Adverse events ofroflumilast creaminclude diarrhea in 3% of patients, headache in 2%, and insomnia, application site pain, urinary tract infection, upper respiratory tract infection, and nausea in 1%. Roflumilast cream should not be used in patients with moderate to severe liver impairment.
Arcutis is an early commercial-stage biopharmaceutical company researching products for treating dermatologic conditions such as scalp and body psoriasis, seborrheic dermatitis, atopic dermatitis, and alopecia areata. Roflumilast cream is a new topical treatment from the company, allowing a greater variety of treatment for plaque psoriasis, which is the most common form of psoriasis in all age groups.
Arcutis submits supplemental new drug application for ZORYVE (roflumilast) Cream 0.3% for expanded indication for the treatment of plaque psoriasis in children down to 2 years of age. Arcutis Biotherapeutics, Inc. December 19, 2022. Accessed December 19, 2022.https://www.globenewswire.com/news-release/2022/12/19/2576249/0/en/Arcutis-Submits-Supplemental-New-Drug-Application-for-ZORYVE-roflumilast-Cream-0-3-for-Expanded-Indication-for-the-Treatment-of-Plaque-Psoriasis-in-Children-Down-to-2-Years-of-Age.html