FDA Accepts sNDA for Dermavant's Tapinarof Cream, 1%

The U.S. Food and Drug Administration (FDA) has accepted Dermavant's Supplemental New Drug Application (sNDA) for tapinarof cream, 1% (VTAMA®), for the treatment of atopic dermatitis in (AD), according to a news release from the manufacturer. 

The FDA assigned a Prescription Drug User Fee Act (“PDUFA”) action date in Q4 2024 for this application. The once-daily, steroid-free topical cream for both acute treatment and long-term management of AD is currently approved for the topical treatment of plaque psoriasis in adults in the U.S. An identical strength and formulation is also currently being evaluated in the ADORING Phase 3 development program for AD.

“The FDA acceptance of our sNDA is an important milestone in our efforts to bring VTAMA cream, as a potentially safe and well-tolerated non-steroidal treatment option, to adults and children as young as 2 years old who suffer from AD,” said Todd Zavodnick, Chief Executive Officer of Dermavant, in a press statement. “Our commitment to patients is unwavering, and we remain highly focused on preparing for the commercial launch of VTAMA cream, subject to FDA approval, for its second indication of AD.”

Dermavant had previously received FDA approval for tapinarof cream, 1%, for the treatment of plaque psoriasis in adults, making it the first non-steroidal topical novel chemical entity launched for psoriasis in the U.S. in over 25 years. The cream is indicated for mild, moderate, and severe plaque psoriasis in adults, with no label safety warnings or restrictions on duration of use or body surface area.

Source: Dermavant press release. April 29, 2024.