Admin_Adham
The FDA has approved topical difamilast for treating mild-to-moderate atopic dermatitis (AD) in adults and children aged 2 years or older, according to a press release from the manufacturer, Acrotech Biopharma.
Difamilast, a topical phosphodiesterase 4 (PDE4) inhibitor that will be marketed as Adquey, in a 1% ointment formulation, is applied twice daily.
Approval was supported by studies that included several phase 3, randomized, controlled trials, which found that after 4 weeks, a higher proportion of patients treated with difamilast achieved Investigator’s Global Assessment success than those who received a vehicle, according to the company. The most common adverse reactions associated with treatment have been nasopharyngitis, reported by 6% of patients, the company said.
Difamilast was approved for AD in Japan in 2021 where it is marketed as Moizerto. The US approval marks the third approval of a PDE4 inhibitor for AD; crisaborole was approved in 2017, and in 2024, topical roflumilast (Zoryve) 0.15% was approved in adults and children aged 6 years or older. In 2025, the FDA approved topical roflumilast 0.05% for treating mild-to-moderate AD in children aged 2-5 years. No date has been identified for when difamilast will be available for clinical use in the US, according to the company.
The meta-analysis was not funded; the individual studies were funded by Otsuka Pharmaceutical Company and Acrotech Biopharma.
