Arcutis Biotherapeutics Announces FDA Acceptance of sNDA for ZORYVE Foam
Introduction
The U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target action date of May 22, 2025 for Arcutis Biotherapeutics’ supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) foam 0.3%. This next-generation phosphodiesterase-4 (PDE4) inhibitor is aimed at treating adults and adolescents ages 12 and over who suffer from scalp and body psoriasis.
Key Information
Almost half of the 9 million individuals in the United States with plaque psoriasis experience involvement of the scalp. The sNDA for ZORYVE is supported by positive efficacy and safety data from Phase 2b and pivotal Phase 3 trials, as well as the long-term ZORYVE cream plaque psoriasis program.
Company Announcement
On September 24, 2024, Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) announced that the FDA has accepted its sNDA for ZORYVE foam. This California-based biopharmaceutical company is focused on developing innovative treatments in immuno-dermatology.
Impact on Individuals
For individuals suffering from scalp and body psoriasis, the acceptance of the sNDA for ZORYVE foam offers new hope for effective treatment. This once-daily medication has shown promising results in clinical trials, providing a potential solution for managing psoriasis symptoms.
Global Implications
The acceptance of ZORYVE foam by the FDA represents a significant advancement in the field of dermatology. This new treatment option has the potential to improve the quality of life for psoriasis patients worldwide, offering a more targeted and effective approach to managing this chronic skin condition.
Conclusion
In conclusion, the acceptance of the sNDA for ZORYVE foam marks a major milestone in the treatment of scalp and body psoriasis. This innovative medication has the potential to make a positive impact on both individuals and the global dermatology community, providing a new avenue for managing this challenging skin condition.
