<\/p>\n
Steroid-free eczema options for babies have long been slim, leaving parents and pediatric dermatologists with few choices for their youngest patients. That may be changing. As reported by Dermatology Times<\/em>, the FDA has accepted an application from Arcutis Biotherapeutics to expand the approval of roflumilast cream (Zoryve) to infants ages 3 months to under 2 years with mild to moderate eczema. If approved, it would give parents of very young children access to a nonsteroidal, once-daily topical option already used by older kids and adults.<\/p>\n In the trial supporting the application, nearly half of treated infants achieved clear or almost clear skin by week four, and itch improved quickly too, with over a third of infants showing meaningful relief from itching in that same timeframe.<\/p>\n<\/div>\n Dermatology Times<\/em> editor-in-chief Christopher Bunick, MD, PhD, pointed to how few advanced options currently exist for this age group. \u201cChildren 3 to 24 months of age have very limited options when it comes to treating their atopic dermatitis with an FDA-approved advanced non-steroidal therapy, regardless of whether that therapy is topical or systemic,\u201d Bunick said. \u201cNews that roflumilast 0.05% cream is on track at the FDA\u2026for approval in this atopic dermatitis population is evidence that potent PDE4 inhibition is effective, safe and tolerable.\u201d<\/p>\n Arcutis president and CEO Frank Watanabe called the FDA\u2019s acceptance of the application a meaningful step forward. \u201cReceiving FDA acceptance of this application is an important milestone toward addressing a significant unmet need for infants living with atopic dermatitis and their families,\u201d Watanabe said.<\/p>\n Side effects reported in the trial skewed mild, mostly stomach upset or cold-like symptoms, in line with what\u2019s been seen in older kids using the cream. The cream isn\u2019t approved for infants yet, and the FDA isn\u2019t expected to make a decision until early 2027. In the meantime, parents managing a baby\u2019s eczema can lean on gentle, barrier-supporting skin care while they wait to see whether this becomes the next nonsteroidal option their pediatric dermatologist can prescribe.<\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":" Steroid-free eczema options for babies have long been s […]<\/p>\n","protected":false},"author":1,"featured_media":3096,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[55],"tags":[],"_links":{"self":[{"href":"https:\/\/nichebeaty.com\/index.php\/wp-json\/wp\/v2\/posts\/3095"}],"collection":[{"href":"https:\/\/nichebeaty.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nichebeaty.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nichebeaty.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/nichebeaty.com\/index.php\/wp-json\/wp\/v2\/comments?post=3095"}],"version-history":[{"count":0,"href":"https:\/\/nichebeaty.com\/index.php\/wp-json\/wp\/v2\/posts\/3095\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nichebeaty.com\/index.php\/wp-json\/wp\/v2\/media\/3096"}],"wp:attachment":[{"href":"https:\/\/nichebeaty.com\/index.php\/wp-json\/wp\/v2\/media?parent=3095"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nichebeaty.com\/index.php\/wp-json\/wp\/v2\/categories?post=3095"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nichebeaty.com\/index.php\/wp-json\/wp\/v2\/tags?post=3095"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}What the Trial Showed<\/h2>\n
Why This Matters for the Youngest Patients<\/h2>\n
What This Means for Parents<\/h2>\n