Westlake Village-based immune-dermatology company Arcutis Biotherapeutics Inc. has submitted its drug to treat fungal dermatitis, along with clinical-trial results, to the U.S. Food and Drug Administration for final approval.
The submission was for a drug called Roflumilast that’s administered through a topical foam and is intended to treat a skin condition known as seborrheic dermatitis. This condition appears as scaly patches, inflamed skin or dandruff, and usually affects oily areas of the body, such as the scalp, face, ears and chest. According to a description from the Mayo Clinic, the condition can be very irritating but is not contagious.
Arcutis said in its announcement that seborrheic dermatitis affects as many as 10 million people in the United States. It is often difficult to treat and can require multiple applications of treatments each day. And many of the treatments involve the use of steroid or steroid-drug combinations, which carry their own side effects.
“Topical therapies are considered the cornerstone of treatment of seborrheic dermatitis,” Frank Watanabe, chief executive of Arcutis, said in the Feb. 16 announcement. “But currently available therapies come with multiple tradeoffs, such as limited duration of use, the need for multiple applications a day to affected areas, skin irritation, and the inability to use on both hair- and non-hair-bearing areas of the body, making for a complex care routine,” he added.
While there have been other once-daily, steroid-free topical drugs developed to treat the condition, none has come to market in over a decade, Watanabe said.
Arcutis said that during a Phase 3 clinical trial, Roflumilast cleared the skin condition in nearly 80% of patients after eight weeks, compared to 58% for the control drug. The most common adverse events to hit the clinical trial population taking Roflumilast during those eight weeks were Covid-19, urinary tract infection, nasopharyngitis, and nausea.