Zoryve™ (roflumilast) cream

Arcutis Biotherapeutics received approval from the U.S. Food and Drug Administration (FDA) on July 29, 2022, for Zoryve™ (roflumilast) cream, 0.3%. A topical phosphodiesterase-4 (PDE4) inhibitor, it is indicated to treat all severity levels of plaque psoriasis for patients who are at least 12 years old. Clinical trial results showed that it reduced symptoms of psoriasis, including in the hard-to-treat intertriginous areas, which are places where two skin surfaces come into contact, such as in the bends of the elbows and knees. Zoryve is rubbed into affected areas of skin once a day, avoiding contact with the eyes, mouth and vagina. It can be used continuously as long as needed. Launch is planned for the middle part of August through regular pharmacy channels. Wholesale acquisition cost (WAC) for a 60gm tube is $825.

At a Glance

• Brand (Generic) Name: Zoryve (roflumilast) cream, 0.3%.
• Manufacturer: Arcutis Biotherapeutics
• Date Approved: July 29, 2022
• Indication: to treat plaque psoriasis, including intertriginous areas, in patients 12 years of age and older
• Dosage Forms Available: 0.3% topical cream
• Launch Date: Around Aug. 15, 2022
• Estimated Annual Cost: Actual cost depends on the amount of skin to be treated and the duration of therapy. WAC for each 60gm tube of Zoryve is $825.
• Psoriasis is an autoimmune disease that involves excessive activity of the immune system. It causes skin cells to grow much faster than normal. As a result, cells build up on the skin’s surface as large, raised spots (plaques). In addition to itchy, painful, red skin, patients who have psoriasis also may experience internal organ damage due to inflammation.
• According to the National Psoriasis Foundation, an estimated 8 million Americans have some degree of psoriasis. Usually showing symptoms when patients are between 15 years and 25 years of age, it is slightly more common among Caucasians than among other ethnic groups and it affects about equal numbers of men and women.
• Zoryve blocks the effects of PDE-4, an enzyme that contributes to inflammation.
• Two phase III clinical trials of Zoryve’s effectiveness and safety enrolled nearly 900 patients who had mild, moderate or severe psoriasis that affected up to 20% of their skin surfaces. Following eight weeks of treatment, approximately 40% of patients in the Zoryve groups had clear or nearly clear skin as compared with fewer than 8% of study participants who used the same cream base that did not contain the active ingredient.
• A few more patients in the group using Zoryve experienced diarrhea or headache than those who used a placebo cream.
• Presently, topical treatment for psoriasis depends mainly on various strength corticosteroid products and forms of vitamin D analogues. Other topical treatments may include anthralin, coal tar and vitamin A.
• Vtama® (tapinarof) Cream, 1% (Dermavant Sciences) was approved in May 2022. It is an aryl hydrocarbon receptor (AhR) agonist indicated to treat adults who have psoriasis. Eucrisa® (crisaborole) ointment, a topical PDE-4 inhibitor, currently is approved in the U.S. only to treat atopic dermatitis.