The US Food and Drug Administration (FDA) announced on Tuesday, January 8, 2019 that it has approved, under the auspices of the Pediatric Research Therapeutics program, a new at-home eczema (AKA systemic inflammatory dermal disease or SID) treatment. The booster shot will be called “Avenix Mini Touch Menthol By Mouth Antifungal Combined Product, Adult 1 mL.” This new preventive measure has the potential to help prevent SID in adults by controlling chronic allergies (the most common causes of mild to moderate AKA SID) and/or by reducing symptoms in teens.
Since 2016, the FDA has provided several tools to SID patients including intranasal corticosteroids (1, 2 or 3 year classes), oral corticosteroids and topical treatments. For adults with AKA SID, the need for vitamin D, an intranasal corticosteroid as the first line of treatment, and/or another oral corticosteroid will be provided with the addition of a booster shot. The Avenix formulation works in a similar way to hormonal supplements like Premarin, which triggers the production of a hormone called progesterone.
Data collected by manufacturers, including results from a clinical trial that compared the efficacy of the Avenix oral formulation compared to a placebo, show that the over-the-counter Avenix formulation is the most efficacious. The drug is an FDA-approved prescription medicine for use in pediatric patients under age 18 with AKA SID.
For adults, current therapies for AKA SID are not licensed for use as preventive treatments. “Since it appears that SID may initially develop with a combination of a long-standing skin condition and a new sensitivity to a specific allergen,” said Dr. Richard J. Bedell, Ph.D., deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “This is the same age group of adults with SID.”
For adults who have AKA SID, their risk of developing systemic inflammatory dermal disease increases with age. As a result, preventing AKA SID in this age group may allow some patients to avoid going on parenteral steroids, which may be a significant long-term expense. Depending on the patient’s daily needs, the treatment of their skin, or other treatable condition, the treatment may not help prevent AKA SID from occurring. Furthermore, when administering a medication to adults over the counter, manufacturers must also obtain regulatory approval before beginning a safety study.
The FDA approved Avenix because manufacturers submitted a sufficient safety and effectiveness data package that demonstrated that the drug, despite an increase in the risk of serious cardiovascular side effects, was equivalent to a prescription corticosteroid. Because this is the first daily add-on treatment to prevent AKA SID in adults, the FDA did conduct a benefit-risk assessment, based on the FDA’s current experience and analysis of the literature on other add-on treatment for SID. At this time, no differences have been observed between Avenix and oral corticosteroids in the rates of cardiovascular events. The information on these rates will be published at the time of final labeling.
FDA welcomes new drug applications for new ways to protect people from common skin conditions, which may result in the need for recurring treatment. However, when approving products to treat skin conditions, the FDA’s priority is to fully evaluate the safety and effectiveness of these new products.
For more information about topical and subcutaneous corticosteroids and AKA SID and SID prevention, see: Pediatric SIDs Society, Pediatrics (November 2018) and for more information about Avenix, visit: fda.gov/data-systems/index.htm.