The US Food and Drug Administration has approved a supplemental New Drug Application expanding the indication for roflumilast (ZORYVE) cream 0.3% for the topical treatment of plaque psoriasis, including intertriginous areas, in pediatric patients aged 2 years and older, according to a press release from Arcutis Biotherapeutics. The therapy was previously approved for adults and pediatric patients aged 6 years and older at a 0.15% dose.
Plaque psoriasis is a chronic, immune-mediated inflammatory skin disease that can begin early in life and may involve sensitive skin areas, including the face and intertriginous regions.
The expanded indication was based on data from the open-label, 4-week Maximal Usage Systemic Exposure (MUSE; ARQ-151-216) study, which evaluated pharmacokinetics, safety, tolerability, and exploratory efficacy in pediatric patients aged 2 to 5 years with plaque psoriasis involving at least 2% body surface area. Additional long-term safety data were obtained from the open-label extension study (ARQ-151-306), which evaluated treatment for up to 24 weeks. According to Arcutis, the safety and efficacy findings were generally consistent with those reported in the phase 3 DERMIS-1 and DERMIS-2 trials in adolescents and adults.
“Although topical steroids are commonly used to treat pediatric plaque psoriasis, they are not recommended on sensitive areas or for long-term, continuous use," said Lisa Swanson, MD, FAAD, of Ada West Dermatology, clinical trial investigator and board-certified pediatric dermatologist. “In clinical studies, ZORYVE cream 0.3% demonstrated consistent safety and efficacy in improving the signs and symptoms of plaque psoriasis as seen in adults and adolescents, and was safe and well tolerated in children as young as age 2. This approval provides physicians and caregivers a targeted topical therapy that can be used anywhere on the body for any duration of time."
Leah Howard, president and chief executive officer of the National Psoriasis Foundation, said “Parents and caregivers of young children with plaque psoriasis have faced a significant treatment gap for years, with very limited options, even though this skin condition can have a profound impact on the child and the entire family." She continued, “The FDA approval of a once-daily, steroid-free topical treatment for children as young as 2 introduces an important new treatment option for a largely overlooked population and represents a significant advancement in pediatric psoriasis care.”
Roflumilast is a topical phosphodiesterase type 4 inhibitor. According to the prescribing information, roflumilast cream 0.3% is contraindicated in patients with moderate to severe liver impairment. The most common adverse reactions reported in plaque psoriasis trials included diarrhea, headache, insomnia, nausea, application-site pain, upper respiratory tract infection, and urinary tract infection.
Source: Arcutis Biotherapeutics
