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The FDA approved tapinarof cream 1% (Vtama) for eczema in individuals ages 2 years and older, drugmaker on Monday.

Approval of the topical aryl hydrocarbon receptor agonist was supported by the . In the vehicle-controlled trials, tapinarof cream led to a significantly higher proportion of patients achieving a score of 0 or 1 (clear or almost clear) on the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD), along with at least a 2-grade improvement from baseline to week 8 (P<0.0001 for both):

• ADORING 1: 45.4% with tapinarof vs 13.9% with vehicle
• ADORING 2: 46.4% vs 18%, respectively

All secondary endpoints significantly favored the tapinarof arm as well. Patients randomized to the drug had superior Eczema Area and Severity Index 75 responses from baseline to week 8 (56-59% vs 21-23%), and participants 12 years and older were more likely to achieve at least a 4-point improvement on the Peak Pruritus Numerical Rating Scale.

"Vtama cream approval in AD [atopic dermatitis] is important because it can be prescribed for children as young as 2 years old. Vtama cream has the potential to bring much needed relief to a significant number of children suffering from this disease," said investigator Adelaide Hebert, MD, of Children's Memorial Hermann Hospital and the McGovern Medical School at UTHealth Houston, in a statement.

"Moreover, because the prevalence of itch makes this condition extremely burdensome to patients and their families, the itch data from the ADORING program demonstrates reduction of one of the condition's most prevalent symptoms with use of Vtama cream," said Hebert.

The company's release noted that itch improvement was reported as early as 24 hours after the first application.

During a long-term extension study (ADORING 3), patients who had achieved complete disease clearance (vIGA-AD score of 0) with tapinarof and discontinued the therapy had a mean treatment-free interval of about 11 weeks.

Safety during the 48-week trial was consistent with the 8-week studies. Adverse events with tapinarof included upper (12%) or lower (5%) respiratory tract infections; folliculitis (9%); headache (4%); asthma, vomiting, ear infection, and pain in the extremities each occurring in 2% of patients; and abdominal pain (1%).

for tapinarof contains no warnings or precautions, contraindications, or restrictions on duration of use.

The drug received its initial approval in 2022 for treating plaque psoriasis in adults.

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