FDA approves Zoryve for treatment of seborrheic dermatitis
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Key takeaways:
- This decision makes Zoryve the first drug approved in this indication with a new mechanism of action in more than 2 decades.
- Approval was supported by positive results from the STRATUM phase 3 trial.
The FDA has approved Zoryve for the treatment of seborrheic dermatitis in individuals aged 9 years and older, Arcutis announced in a press release.
The approval makes Zoryve (roflumilast) topical foam, 0.3%, a once-daily steroid-free foam, the first drug approved for seborrheic dermatitis with a new mechanism of action in more than 2 decades.
“Most providers out there have been using the same two mechanisms — topical corticosteroids and antifungals — to manage all of their seborrheic dermatitis patients for almost the entire time that they’ve been in practice,” Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis, told Healio. “Now, when a patient comes in and asks if there is anything to help them besides steroids and antifungals, for the first time in 20 years, the answer to that question is yes.”
The approval was based on results from the STRATUM phase 3 study. At week 8, 79.5% of patients treated with Zoryve achieved the primary endpoint of IGA success compared with 58% of vehicle-treated patients (P < .0001). Further, 50.6% of those treated with Zoryve reached complete disease clearance.
Patients treated with Zoryve achieved disease clearance as early as week 2. Additionally, 28% reported rapid itch relief in 48 hours vs. 13% of vehicle-treated patients (P = .0024).
In assessing itch using the Worst Itch Numerical Rating Scale, a higher proportion of patients treated with Zoryve vs. vehicle also achieved an equal to or greater than 4-point reduction in itch at week 8 (62.8% vs. 40.6%, respectively; P = .0001).
In the study, Zoryve was considered to be well tolerated with a favorable safety profile for up to 52 weeks of treatment.
“For us to be able to bring a new drug to a disease that hasn’t really received the appropriate focus from the pharmaceutical industry is a very exciting place to be for us as a company,” Burnett told Healio. “This really highlights our ability to understand and collaborate with the dermatology community of both patients and doctors.”
Zoryve will be available to key wholesaler and dermatology pharmacy channels by the end of January 2024, according to the release.