sNDA Submitted for Roflumilast Foam 0.3% for Scalp and Body Psoriasis
A supplemental New Drug Application (sNDA) has been submitted for ZORYVE (roflumilast) foam 0.3%, a once-daily, next-generation phosphodiesterase-4 (PDE4) inhibitor, for the treatment of adults and adolescents ages 12 and over with scalp and body psoriasis, Arcutis Biotherapeutics, Inc., announced in a press release.
“Nearly half of all individuals with plaque psoriasis have involvement of the scalp. Hair-bearing areas present unique treatment challenges that are not easily addressed with creams or ointments. Individuals with plaque psoriasis need steroid-free treatment options that clear plaques anywhere on the body and relieve burdensome symptoms, such as itch and flaking,” said Melinda Gooderham, MSc, MD, FRCPC, medical director, SKiN Centre for Dermatology, investigator with Probity Medical Research, and clinical trial investigator. “Clinical data show that investigational once-daily ZORYVE foam effectively and reliably cleared both scalp and body psoriasis across all efficacy endpoints compared to vehicle, including 67% of participants achieving Scalp-Investigator Global Assessment Success with ZORYVE foam at 8 weeks. These data demonstrate that ZORYVE foam, if approved, would be an important new treatment option for those living with psoriasis.”
Frank Watanabe, president and chief executive officer of Arcutis, noted that this is the company’s fifth topical roflumilast regulatory submission in the United States in less than 3 years.
"Based on the rapid adoption of ZORYVE foam in seborrheic dermatitis due to the simplicity of using one treatment anywhere on the body, including hair-bearing areas, we believe there is great potential for its adoption in scalp and body psoriasis, once approved,” Watanabe said. “Our team’s ability to execute our clinical development and commercial strategies reinforces Arcutis’ leadership in medical dermatology and positions the ZORYVE portfolio as a new standard of care for the effective treatment of multiple immune-mediated, chronic skin diseases. I would like to thank the clinical investigators, study coordinators, patients, and caregivers who participated in our clinical trials.”