Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, announced that its co-development partner Arcutis Biotherapeutics Inc., (NASDAQ: ARQT), has received approval from the U.S. Food and Drug Administration (FDA) for a supplementary New Drug Application (sNDA) for Zoryve cream (roflumilast). This clearance is for treating mild to moderate atopic dermatitis (AD) in adults and children aged six and above.
The approval follows successful clinical trials, including the Phase III INTEGUMENT-1 and INTEGUMENT-2 studies, which met their primary endpoint of IGA success. This indicates that vIGA AD was rated as “cleared” or “essentially cleared,” showing a 2-point improvement from baseline at week 4. Zoryve cream demonstrated a rapid and significant reduction in itching within 24 hours of the initial application compared to the placebo. Over 40% of the treated subjects achieved EASI-75 by the fourth week, a significant improvement over the approximately 20% in the placebo group. The cream also exhibited good overall tolerability.
Roflumilast, the active ingredient in Zoryve, is a phosphodiesterase4 (PDE4) inhibitor that modulates the production of pro-inflammatory mediators and anti-inflammatory agents. It is already approved in the U.S. for the treatment of AD, seborrheic dermatitis, and plaque psoriasis.
In August 2023, Huadong Medicine secured an exclusive licensing deal worth USD 94.25 million with Arcutis, covering Daxas (roflumilast, including cream Zoryve and foam agent ARQ-154) for external preparations in Greater China and South-East Asia.- Flcube.com
