Westlake Village-based Arcutis Biotherapeutics has submitted a new drug application to the U.S. Food and Drug Administration for its roflumilast cream, a treatment for mild to severe plaque psoriasis.

If approved by the FDA, the cream would be the company’s first commercial product.


Plaque psoriasis is a disease characterized by itchy, thick, red and scaly skin patches that, according to Arcutis, affects about 8.6 million people in the United States.


The disease presents a challenge for treatment when found in anatomical areas such as the face, elbows, knees, scalp, and areas where two skin areas may touch or rub together. According to Arcutis, current topical treatments put patients and physicians in hard positions, forcing them to make tradeoffs between tolerability and long-term use.


The late-stage biopharmaceutical company’s roflumilast can be used chronically and has demonstrated in clinical trials a combination of tolerability and safety.


“Today is a critical milestone for Arcutis in our efforts to bring innovative treatments to dermatologists and their patients, and is a reflection of our deep dermatology expertise,” Frank Watanabe, chief executive of Arcutis, said in a statement.


Shares of Arcutis (ARQT) closed down 25 cents, or just under 1 percent, to $24.96 on the Nasdaq Monday, a day when the market closed down more than 2 percent.