Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT) witnessed an 8.59% surge in its stock on the US stock charts today, reaching a trading value of $2.78 as of the last check. This upward movement in Arcutis stock is a direct result of the regulatory authority’s approval.
Arcutis (ARQT) formally declared that the U.S. Food and Drug Administration (FDA) has granted approval for the new drug application (NDA) concerning ZORYVE. ZORYVE (roflumilast) stands as a topical foam, 0.3%, designed for treating seborrheic dermatitis in individuals aged 9 years and above.
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The ZORYVE foam exhibits swift disease clearance and a notable reduction in itch, with nearly 80% of individuals achieving the primary efficacy endpoint of IGA Success and just over 50% experiencing complete clearance at Week 8 in the STRATUM trial. It is worth noting that ZORYVE marks the first drug approved for seborrheic dermatitis with a new mechanism of action in over two decades, presenting itself as a once-daily steroid-free foam.
The challenges associated with living with seborrheic dermatitis, including disease clearance, treatment adherence issues due to inefficacy, difficulties in treating specific body areas, inconvenient treatment regimens, and safety concerns with long-term use, have been substantial. ZORYVE foam addresses these challenges by offering a convenient once-daily, steroid-free topical treatment applicable to all body areas, including those with hair, without any restrictions on duration of use.
This innovative topical treatment effectively clears and manages the disease, simplifying its overall management for the vast number of adults and adolescents grappling with seborrheic dermatitis. Seborrheic dermatitis, a prevalent chronic and recurrent inflammatory skin disease, impacts over 10 million individuals in the United States.
Arcutis is poised to launch ZORYVE foam imminently, with its commercial team dedicated to ensuring affordable access to this novel treatment. The company aims to make ZORYVE foam widely accessible through key wholesaler and dermatology pharmacy channels, presenting it as a new treatment option by the conclusion of January 2024.
