FDA accepts supplemental new drug application for roflumilast cream for atopic dermatitis

Key takeaways:

• The supplemental new drug application was supported by three phase 3, one phase 2 and two phase 1 studies.
• The FDA has set a Prescription Drug User Fee Act target action date of July 7, 2024.

The FDA has accepted the supplemental new drug application for roflumilast cream 0.15% for adults and children aged as young as 6 years with atopic dermatitis, Arcutis Biotherapeutics announced in a press release.

“With this filing acceptance, we are one step closer to potentially providing a new topical option for the millions of Americans living with atopic dermatitis,” Frank Watanabe, president and CEO of Arcutis, said in the release. “Given the prevalence of this disease in both children and adults, as well as the need for better long-term management, we believe once-daily, steroid-free roflumilast cream has the potential to become the new standard of care in atopic dermatitis.”

Once-daily roflumilast cream is a nonsteroidal topical formulation of a highly potent and selective phosphodiesterase-4 inhibitor. The non-greasy cream, formulated with HydroARQ Technology, is quickly absorbed without disrupting the skin barrier, according to the press release.

The submission was supported by results from three phase 3 programs, a phase 2 dose ranging study and two phase 1 pharmacokinetic studies.

In two of the identical phase 3 studies, INTEGUMENT-1 and INTEGUMENT-2, the primary endpoint was IGA success, defined as validated IGA for atopic dermatitis scores of 0/1 (clear/almost clear) and a two-grade improvement from baseline by week 4 of the study. This endpoint was achieved by 32% and 28.9% of roflumilast-treated patients, respectively, compared with 15.2% and 12% of those treated with vehicle (P < .0001 for both).

Additionally, 43.2% and 42% of children and adults treated with roflumilast cream also achieved EASI 75 in both INTEGUMENT studies, respectively, vs. 22% and 19.7% of patients treated with vehicles (P < .0001 for both).

The drug was also well tolerated with treatment-emergent adverse events, most of which were mild to moderate in severity, occurring in no more than 2.9% of patients.

The FDA has set a Prescription Drug User Fee Act target action date of July 7, 2024, for roflumilast 0.15%.