Arqt fda approval

Arcutis Biotherapeutics has received FDA approval for its drug ZORYVE (roflumilast) in several indications:

1. Seborrheic Dermatitis:
   • ZORYVE foam, 0.3%, was approved in December 2023 for the treatment of seborrheic dermatitis in individuals aged 9 years and older.
   • This represents a significant milestone as it is the first drug approved for seborrheic dermatitis with a new mechanism of action in over two decades.
   • The drug provides rapid disease clearance and significant reduction in itch, with nearly 80% of individuals achieving the primary efficacy endpoint of IGA Success and just over 50% reaching complete clearance at Week 8 in the STRATUM trial.
2. Atopic Dermatitis:
   • A supplemental New Drug Application (sNDA) for roflumilast cream 0.15% was accepted by the FDA in November 2023 for the treatment of atopic dermatitis (AD) in adults and children down to age 6.
   • The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of July 7, 2024, for this application.
3. Plaque Psoriasis:
   • ZORYVE cream, 0.3%, was approved in July 2022 for the treatment of plaque psoriasis in patients 12 years of age or older.
   • The drug is the first and only topical phosphodiesterase-4 (PDE4) inhibitor approved for the treatment of plaque psoriasis, including intertriginous areas.
   • It provides rapid clearance of psoriasis plaques and reduces itch in all affected areas of the body.

These approvals are expected to significantly enhance Arcutis' commercial prospects, particularly with the upcoming PDUFA decision on the sNDA for AD treatment. The company's stock price has shown volatility but also significant appreciation following the seborrheic dermatitis approval, reflecting investor confidence in the company's pipeline and regulatory strategy.