FDA accepts new drug application for roflumilast cream

The FDA has accepted a new drug application for roflumilast cream, Arcutis announced in a press release.

Roflumilast cream (ARQ-151) is a once-daily topical treatment for psoriasis in adults and adolescents and has a highly potent, selective inhibitor of phosphodiesterase type 4 (PDE4).

The new drug application is supported by the DERMIS1 and DERMIS2 trials. In the identical, phase 3, randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center studies, roflumilast cream attained its primary endpoint of an Investigator Global Assessment success rate of 46.4% vs. 6.1% (P < .0001) in vehicle and 37.5% vs. 6.9% in vehicle (P < .0001) for DERMIS1 and DERMIS2, respectively. Roflumilast cream also showed statistically significant improvement over vehicle in key secondary endpoints, including measurements in intertriginous-IGA, Psoriasis Area Severity Index-75 and Worst Itch-Numerical Rating Scale, as well as patient perceptions of symptoms measured by the Psoriasis Symptoms Diary. The trials showed a favorable safety and tolerability profile.

“Topical treatments are the standard therapies for the majority of psoriasis patients, but they often come with compromises between efficacy, tolerability and long-term use,” Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis, said in the release. “With these challenges in mind, we developed roflumilast cream as a formulation for chronic use anywhere on the body, including the face and sensitive intertriginous areas.”

The FDA assigned the NDA a prescription drug user free act target action date of July 29, 2022, according to the release.