FDA Approves Steroid-Free Zoryve for Plaque Psoriasis

Zoryve, the first topical PDE4 inhibitor approved to treat patients with plaque psoriasis, will be available by mid-August.

The FDA has approved the new drug application (NDA) for Zoryve (roflumilast) cream for the treatment of plaque psoriasis in patients 12 years of age or older. Zoryve is a once-daily, steroid-free cream and is the first topical phosphodiesterase-4 (PDE4) inhibitor approved for this indication.

Developed by Arcutis Biotherapeutics, Zoryve will be available by mid-August.

“In multiple clinical trials, Zoryve was proven to be safe and effective, with improvements in disease clearance in hard-to-treat areas like knees and elbows, as well as in sensitive areas such as the face, genitalia, and intertriginous areas,” Mark Lebwohl M.D., principal investigator, said in a press release. He is dean for clinical therapeutics and chairman emeritus of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai.

The approval was based on the pivotal DERMIS-1 and DERMIS-2 phase 3 studies. In these trials, significantly more patients treated with Zoryve achieved Investigator Global Assessment (IGA) success at week 8 compared with vehicle: 42% in DERMIS-1 and 37% in DERMIS-2 with Zoryve compared with 6% in DERMIS-1 and 7% in DERMIS-2 with vehicle. Zoryve also improved the severity and impact of itch by week 2.

Additionally, Zoryve demonstrated improvement in intertriginous psoriasis, a variant of psoriasis that is associated with inflammatory lesions in skin folds, as measured by Intertriginous IGA of 72% vs. 14% for vehicle in DERMIS-1 and 68% vs. 17% in vehicle at DERMIS-2 at week 8.

In both trials, Zoryve was well-tolerated with a favorable safety and tolerability profile. The most common adverse reactions reported included diarrhea, headache, insomnia, nausea, application site pain, upper respiratory tract infection, and urinary tract infection.

Arcutis will offer a patient support program to help commercially insured patients get access and help navigate the payer process. The company will also offer the Arcutis Cares patient assistance program – the first of its kind for a topical psoriasis treatment – that will provide Zoryve at no cost for financially eligible patients who are uninsured or underinsured.