‘FDA Approves Arcutis Biotherapeutics’ Drug for Seborrheic Dermatitis\n\nThe U.S. Food and Drug Administration (FDA) has approved Arcutis Biotherapeutics’ drug for treating seborrheic dermatitis in individuals nine years of age and older. This marks the first topical drug with a new mechanism of action to be approved for this condition in over two decades.\n\nSeborrheic dermatitis is a common, chronic, and recurrent inflammatory skin disease that affects more than 10 million people in the United States. It causes red patches covered with large, greasy, flaking yellow-gray scales, and persistent itch. The condition can be especially burdensome for those with hair loss, as it often occurs in areas of the body with oil-producing glands.\n\nArcutis Biotherapeutics’ drug, called ZORYVE foam, is a once-daily, steroid-free topical treatment that can be used on all affected areas of the body, including hair-bearing areas, with no limitations on duration of use. In clinical trials, nearly 80% of individuals achieved the primary efficacy endpoint of IGA Success, and over 50% reached complete clearance at Week 8.\n\n”We know from dermatology clinicians and those living with seborrheic dermatitis that there has been a real struggle with disease clearance and treatment adherence due to lack of efficacy, difficulty treating certain body areas, inconvenient treatment regimens, and concerns about safety with long-term use,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. “ZORYVE foam is a once-daily, steroid-free topical treatment that can be used anywhere on the body, including hair-bearing areas, with no limitation on duration of use.”\n\nThis approval is a significant milestone for Arcutis Biotherapeutics and offers a new treatment option for the millions of adults and adolescents living with seborrheic dermatitis. The company expects the commercial product to be available by the end of January.’
‘FDA Approves Arcutis Biotherapeutics’ Drug for Seborrheic Dermatitis\n\nThe U.S. Food and Drug Administration (FDA) has approved Arcutis Biotherapeutics’ drug for treating seborrheic dermatitis in individuals nine years of age and older. This marks the first topical drug with a new mechanism of action to be approved for this condition in over two decades.\n\nSeborrheic dermatitis is a common, chronic, and recurrent inflammatory skin disease that affects more than 10 million people in the United States. It causes red patches covered with large, greasy, flaking yellow-gray scales, and persistent itch. The condition can be especially burdensome for those with hair loss, as it often occurs in areas of the body with oil-producing glands.\n\nArcutis Biotherapeutics’ drug, called ZORYVE foam, is a once-daily, steroid-free topical treatment that can be used on all affected areas of the body, including hair-bearing areas, with no limitations on duration of use. In clinical trials, nearly 80% of individuals achieved the primary efficacy endpoint of IGA Success, and over 50% reached complete clearance at Week 8.\n\n”We know from dermatology clinicians and those living with seborrheic dermatitis that there has been a real struggle with disease clearance and treatment adherence due to lack of efficacy, difficulty treating certain body areas, inconvenient treatment regimens, and concerns about safety with long-term use,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. “ZORYVE foam is a once-daily, steroid-free topical treatment that can be used anywhere on the body, including hair-bearing areas, with no limitation on duration of use.”\n\nThis approval is a significant milestone for Arcutis Biotherapeutics and offers a new treatment option for the millions of adults and adolescents living with seborrheic dermatitis. The company expects the commercial product to be available by the end of January.’$ARQT2023-12-20T06:10:56.825Z
