Is Arqt going to get approval from fda

Arcutis is highly likely to receive FDA approval for its roflumilast cream 0.15% for the treatment of atopic dermatitis. Here's why:

1. Positive FDA Action: The FDA has already accepted Arcutis' sNDA in November 2023, which is a strong indicator of the drug's potential for approval. The agency's acceptance of the application is a significant milestone and suggests that the FDA has found the safety and efficacy data from three phase 3 programs, including INTEGUMENT-1 and INTEGUMENT-2, to be compelling.
2. PDUFA Goal Date: The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of July 7, 2024, for a decision on the application. This is a formal commitment to a timeline for review, and the fact that the FDA has not requested additional information suggests that the review process is progressing smoothly.
3. Lack of Extension Request: Arcutis has not reported any extension requests from the FDA, which is a positive sign. If the FDA needed more time to review the application or requested additional data, Arcutis would likely have announced it. However, the company has stated that the FDA is working to finalize the action letter, which points towards a positive outcome.
4. Previous FDA Approvals: Arcutis has a history of FDA approvals, including the green light for ZORYVE® (roflumilast) Topical Foam for seborrheic dermatitis in 2023. This previous success adds to the confidence that the FDA will approve roflumilast cream for atopic dermatitis, especially as the mechanisms and data from both conditions are related.

In conclusion, the FDA approval for Arcutis' roflumilast cream 0.15% for atopic dermatitis is highly anticipated, and all signs point towards a favorable outcome.