FDA approves ZORYVE cream for atopic dermatitis in young children

WESTLAKE VILLAGE, Calif. - Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a biopharmaceutical company with impressive 99.5% revenue growth over the last twelve months, announced Monday that the U.S. Food and Drug Administration has approved ZORYVE (roflumilast) cream 0.05% for treating mild to moderate atopic dermatitis in children aged 2 to 5 years. According to InvestingPro data, the company maintains strong gross margins of 89.1%, reflecting efficient production capabilities.

The once-daily, steroid-free treatment can be used on any part of the body for any duration, providing an alternative to topical steroids for the approximately 1.8 million children in this age group who are treated for the condition in the U.S.

In clinical trials, ZORYVE demonstrated rapid improvement in atopic dermatitis symptoms, with about 40% of children achieving a 75% improvement in disease severity after four weeks. Additionally, more than one-third of children experienced meaningful itch relief during the same period.

"It is essential to have safe and effective treatments for children, who are often diagnosed with atopic dermatitis at a young age and can live with the condition across their lifetime," said Lawrence F. Eichenfield, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego and study investigator, according to the press release.

The approval is based on results from the INTEGUMENT-PED Phase 3 trial, a long-term extension study, and a Phase 1 pharmacokinetic study. The most common side effects reported included upper respiratory tract infection, diarrhea, vomiting, rhinitis, conjunctivitis, and headache.

This marks the sixth FDA approval for the ZORYVE portfolio in just over three years. Arcutis expects to make the product commercially available by the end of October 2025.

The company offers support programs to help patients access the medication, including the ZORYVE Direct Program and the Arcutis Cares patient assistance program for eligible uninsured or underinsured patients.

In other recent news, Arcutis Biotherapeutics reported its second-quarter 2025 earnings, surpassing both earnings per share (EPS) and revenue forecasts. The company posted an EPS of -$0.13, beating the projected -$0.17, and reported revenue of $81.5 million, exceeding expectations by 11.26%. Additionally, Arcutis has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration to expand the use of its ZORYVE cream for treating plaque psoriasis in children as young as two years old. If approved, ZORYVE would become the first topical PDE4 inhibitor indicated for this age group.

In another development, Palvella Therapeutics has appointed David W. Osborne, Ph.D., as Chief Innovation Officer. Dr. Osborne, who co-founded Arcutis Biotherapeutics and served as its Chief Technical Officer, brings extensive experience in developing topical therapies for skin diseases. His contributions include the development of ZORYVE cream and foam. These recent developments reflect ongoing strategic moves within both companies.

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