FDA pens action letter in response to roflumilast cream 0.15% sNDA for atopic dermatitis

Key takeaways:

• The FDA is preparing an action letter for Arcutis in response to its application for roflumilast cream 0.15% for atopic dermatitis.
• The FDA has not indicated the PDUFA date of July 7 will be extended.

The FDA is working to finalize an action letter regarding Arcutis’ supplemental new drug application for roflumilast cream 0.15% indicated for atopic dermatitis, the company announced in a press release.

Previously, the FDA had set a Prescription Drug User Fee Act goal date of July 7 for the supplemental new drug application (sNDA) of roflumilast cream 0.15% for the treatment of mild to moderate AD in adults and children aged as young as 6 years. With no decision made as the date passed, Arcutis announced that it has been in communication with the FDA regarding the application.

The FDA has told the company that it is working on finalizing an action letter; however, it did not indicate that the PDUFA date would be extended.

“We would like to emphasize that the FDA has not requested any additional information related to our sNDA. This speaks to the completeness and quality of our submission, as we have worked diligently to provide all necessary data and meet all regulatory requirements,” Frank Watanabe, president and CEO of Arcutis, said in the release. “We are in close contact with the FDA and anticipate receiving our action letter soon. Pending approval, we look forward to delivering this new innovative treatment in roflumilast cream to the millions suffering from atopic dermatitis.”