FDA Approves Arcutis Biotherapeutics' Lead Drug For Scaly Skin Disorder

The FDA approved Arcutis Biotherapeutics Inc's ARQT Zoryve (roflumilast) topical foam, 0.3% for seborrheic dermatitis in individuals nine years and older. 

Zoryve is a once-daily steroid-free foam and the first drug approved for seborrheic dermatitis with a new mechanism of action in over two decades.

Seborrheic dermatitis affects more than 10 million people in the U.S. and is a common, chronic, and recurrent inflammatory skin disease that causes red patches covered with large, greasy, flaking yellow-gray scales and persistent itch.

In the STRATUM trial, Zoryve foam provided rapid disease clearance as early as Week 2 and significant itch relief in as little as 48 hours. In addition, almost 80% of patients achieved treatment success at Week 8. 

Arcutis intends to make Zoryve foam widely available via key wholesaler and dermatology pharmacy channels as a new treatment option by the end of January 2024. 

In September, Arcutis Biotherapeutics released data from the INTEGUMENT-PED Phase 3 trial of roflumilast cream 0.05% in children ages 2 to 5 years with mild to moderate atopic dermatitis. 

For the primary endpoint, 25.4% of children treated once daily with roflumilast cream achieved Investigator Global Assessment Success compared to 10.7% of children treated with the vehicle at Week 4, with significant improvements seen as early as Week 1.

Zoryve cream is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients six years and older.

Price Action: ARQT shares are up 22.54% at $2.99 during the premarket session on the last check Monday.