FDA approves Zoryve for atopic dermatitis in adults, children
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Key takeaways:
- Zoryve (roflumilast) cream 0.15% is approved for the treatment of mild to moderate atopic dermatitis.
- The approval was supported by results from three phase 3 studies, a phase 2 study and two phase 2 studies.
The FDA has approved Zoryve cream 0.15% for the treatment of mild to moderate atopic dermatitis in adult and pediatric patients aged 6 years and older, Arcutis announced in a press release.
“The AD population overall in the U.S. is about 26 million patients, and just shy of 10 million of them are pediatric,” Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis, told Healio. “Many of those patients have been trying to manage their disease since they were infants, because 90% of AD cases occur before 5 years of life, making this a really large group of patients that are looking for new treatments.”
Zoryve (roflumilast) cream 0.15% is a steroid-free, once-daily, topical phosphodiesterase 4 (PDE4) inhibitor. In its various formulations, Zoryve has been approved for both plaque psoriasis and seborrheic dermatitis, making atopic dermatitis its third indication.
“Now, with this approval for ages 6 and above in AD, we’re addressing three of the most commonly seen inflammatory diseases in dermatology health care providers’ offices,” Burnett said.
Following a delay in a decision from the FDA, the approval of this supplemental new drug application was supported by positive results from three phase 3 studies, a phase 2 study and two phase 1 studies.
Two of the phase 3 trials, INTEGUMENT-1 and INTEGUMENT-2, achieved their primary endpoints of IGA success, defined as validated IGA for Atopic Dermatitis scores of 0/1 and a two-grade improvement from baseline by week 4 of the study. This endpoint was achieved by 32% of Zoryve-treated patients in INTEGUMENT-1 and 28.9% of roflumilast-treated patients in INTEGUMENT-2, which compared with 15.2% and 12% of vehicle-treated patients, respectively (P < .0001 for both).
Results from the third phase 3 study, INTEGUMENT-OLE, were recently presented at the Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference. This long-term, extension trial showed Zoryve kept a patients’ AD under control for up to 56 weeks with no new safety signals.
“As we know, itching is the primary symptom reported by AD patients that really drives impact of quality of life,” Burnett said. “So, what I think is really exciting with this approval in AD, is not only having a nonsteroidal product that’s suitable for long term treatment, but also works quickly on lesions and itching.”
According to the press release, Zoryve cream 0.15% will be available via key wholesaler and dermatology pharmacy channels as a new treatment option by the end of July.
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