FDA Approves Zoryve for Eczema

On Thursday, July 11, 2024, the U.S. Food and Drug Administration (FDA) announced its approval of Zoryve (roflumilast) cream, 0.15 percent, for treating mild-to-moderate atopic dermatitis in adults and children aged six and older. This new medication is a once-daily, steroid-free cream that will be available by the end of July, according to the company.

The FDA's decision was influenced by the findings from the INTEGUMENT-1 and INTEGUMENT-2 phase 3 clinical trials. In these trials, a total of 1,337 individuals with mild-to-moderate atopic dermatitis participated. They were assigned either Zoryve cream, 0.15 percent, or a vehicle cream to be applied once daily over a four-week period. Results from these studies were promising: around 40 percent of those treated with Zoryve cream achieved a validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) score of clear (0) or almost clear (1) by the fourth week. Specifically, INTEGUMENT-1 saw 41.5 percent of participants reach this score compared to 25.2 percent for the vehicle; INTEGUMENT-2 had 39.0 percent versus 16.9 percent, respectively. Significant improvements were noticeable as early as the first week of treatment.

Furthermore, over 40 percent of participants using Zoryve cream experienced a 75 percent reduction in their Eczema Area and Severity Index (EASI-75) by the fourth week. In the INTEGUMENT-1 trial, 43.2 percent of participants achieved this improvement compared to 22.0 percent for the vehicle. Similarly, in INTEGUMENT-2, 42.0 percent reached EASI-75 compared to 19.7 percent for the vehicle.

Dr. Jonathan Silverberg, a dermatologist at the George Washington University School of Medicine in Washington, D.C., commented on the significance of this development. He noted that individuals with atopic dermatitis often endure severe itching, rashes, and sensitive skin, necessitating treatments that are both effective and safe. "Zoryve was developed with the atopic dermatitis patient in mind, to deliver the drug in a moisturizing vehicle that is formulated without common sensitizers or irritants and does not further disrupt the abnormal skin barrier," Dr. Silverberg stated.

The approval of Zoryve was granted to Arcutis Biotherapeutics. This new treatment option is expected to address the needs of those suffering from atopic dermatitis by providing a non-steroidal, well-tolerated alternative that also helps to maintain the skin's moisture and integrity.