Arcutis scores FDA approval for new foam treatment for common skin condition

Cal­i­for­nia-based Ar­cutis Bio­ther­a­peu­tics on Fri­day won FDA ap­proval for a new foam-based skin treat­ment for se­b­or­rhe­ic der­mati­tis in in­di­vid­u­als 9 years of age and old­er.

The new top­i­cal foam, known as Zo­ryve (rof­lu­mi­last), is a phos­pho­di­esterase-4 in­hibitor and will be avail­able by the end of Jan­u­ary 2024, the com­pa­ny said. Ar­cutis said the foam will be priced the same as its ap­proved cream for­mu­la­tion, which has a price of $858 a tube. The cream ver­sion of Zo­ryve first won ap­proval in 2022 for the treat­ment of plaque pso­ri­a­sis in pa­tients 12 years of age or old­er. Rof­lu­mi­last first won FDA ap­proval as an oral drug in 2011 for As­traZeneca un­der the brand name Dalire­sp, and to re­duce the risk of COPD flare-ups.

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