China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its US partner Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT) has filed a supplementary New Drug Application (sNDA) for Zoryve cream (roflumilast) 0.05% with the US Food and Drug Administration (FDA). The application seeks approval for the topical use of Zoryve in children aged 2 to 5 years with mild to moderate atopic dermatitis (AD). The FDA has set a PDUFA target date of October 13, 2025, for this review.
Drug Mechanism and Profile
Roflumilast, the active ingredient in Zoryve cream, inhibits phosphodiesterase-4 (PDE4), an enzyme involved in inflammation. This inhibition helps reduce pro-inflammatory mediators and increase anti-inflammatory molecules, making it effective in treating inflammatory skin conditions. Zoryve cream has already received approval in the US for the treatment of AD, seborrheic dermatitis, and plaque psoriasis.
Clinical Trial Success
The sNDA is supported by positive results from the pivotal Phase III INTEGUMENT-PED study (4 weeks), the long-term extension INTEGUMENT OLE study (52 weeks), and a Phase I pharmacokinetic study. The INTEGUMENT-PED study demonstrated rapid symptom improvement, with 25.4% of patients achieving “clear” or “almost clear” vIGA-AD scores by Week 4, the primary endpoint. The trial also achieved all pre-set secondary endpoints, showing that Zoryve rapidly alleviates itching with good tolerability during treatment.
Partnership and Licensing Agreement
Huadong Medicine entered into a licensing deal with Arcutis in August 2023, valued at USD 94.25 million. This agreement granted Huadong exclusive rights to Daxas (roflumilast), including Zoryve cream and foam agent ARQ-154, for external preparations in Greater China and South-East Asia.-Fineline Info & Tech
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