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Arcitis Zoryve面霜sNDA被FDA接受，用于治疗儿童斑块状银屑病

2025-11-17 22:05

Arcutis Biotherapeutics(ARQT) 0

The U.S. FDA has accepted a sNDA from Arcutis Biotherapeutics (ARQT) for its Zoryve (roflumilast) cream for the treatment of plaque psoriasis in children ages two to five years old.
The application has a user fee date of June 29, 2026.
Zoryve is a once-daily applied, targeted topical phosphodiesterase-4 (PDE4) inhibitor. It is already approved in plaque psoriasis for children six years and older, and adults.
The sNDA is supported by data from a four-week study in children ages two to five and a long-term open-label study.

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