Drugs

Arcutis Bio Files sNDA for Zoryve Expanded Use

FDA has accepted for review an Arcutis Biotherapeutics supplemental NDA for Zoryve (roflumilast) foam 0.3%, a once-daily, next-generation phosphodiesterase-4 (PDE4) inhibitor for treating adults and adolescents ages 12 and over with scalp and body psoriasis. The agency has set a user fee review action target date of 5/22/2025.

The sNDA is supported by data from Arcutis’ pivotal ARRECTOR Phase 3 trial, which the company says met its co-primary endpoints with 66.4% of individuals treated with roflumilast foam achieving scalp-investigator global assessment success compared to 27.8% of individuals treated with a matching vehicle foam at Week 8. It also notes that 45.5% of those treated with roflumilast foam achieved body-investigator global assessment success compared to 20.1% of individuals treated with a matching vehicle foam at Week 8.

Additionally, Arcutis says the trial showed that a significant proportion of roflumilast-treated patients saw a reduction in itch, with some patients experiencing rapid relief in scalp itch 24 hours following first application compared to the vehicle treatment.

Zoryve foam is currently approved for treating seborrheic dermatitis in adult and pediatric patients nine years of age and older, according to the company. It is indicated for topical treatment of plaque psoriasis and mild to moderate atopic dermatitis in adult and pediatric patients six years of age and older.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome