The Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for tapinarof cream for the treatment of plaque psoriasis in adults.
The NDA is supported by data from 2 identical phase 3 studies, PSOARING 1 (ClinicalTrials.gov Identifier: NCT03956355) and PSOARING 2 (ClinicalTrials.gov Identifier: NCT03983980), which assessed the efficacy and safety of tapinarof, a novel, aryl hydrocarbon receptor modulating agent, in 1025 patients aged 18 to 75 years with plaque psoriasis. Patients were randomized 2:1 to receive tapinarof cream 1% or vehicle once daily for 12 weeks.
Findings showed that the primary endpoint was met in both trials. At week 12, treatment with tapinarof cream was associated with statistically significant improvement in Physician Global Assessment (PGA) score of clear (0) or almost clear (1) with a minimum 2-grade improvement compared with vehicle from baseline (both P <0.0001).
The NDA also includes data from PSOARING 3 (ClinicalTrials.gov Identifier: NCT04053387), a long-term open-label safety study. Patients who completed the PSOARING 1 or 2 studies were eligible to enroll in the trial. Data from an interim analysis showed that 57.3% (n=298/520) of patients who entered the study with a PGA score of at least 2 achieved a PGA score of 0 or 1; 39.2% (n=299/763) of patients achieved complete disease clearance with a PGA score of 0.
The most commonly reported adverse events with tapinarof were folliculitis, contact dermatitis, and upper respiratory tract infection. There were no treatment-related serious adverse events reported.
A Prescription Drug User Fee Act (PDUFA) target date for the second quarter of 2022 has been set for the application.
- Dermavant announces FDA acceptance for filing of New Drug Application (NDA) for tapinarof cream for the treatment of adults with plaque psoriasis. News release. Dermavant Sciences. Accessed August 10, 2021. https://www.businesswire.com/news/home/20210810005299/en/Dermavant-Announces-FDA-Acceptance-for-Filing-of-New-Drug-Application-NDA-for-Tapinarof-Cream-for-the-Treatment-of-Adults-with-Plaque-Psoriasis.
- Positive data from PSOARING 3 support long-term use of tapinarof cream in adults with plaque psoriasis, with durable (on-therapy) and remittive (off-therapy) benefits. News release. Dermavant Sciences. February 18, 2021. Accessed August 10, 2021. https://www.dermavant.com/positive-data-from-psoaring-3-support-long-term-use-of-tapinarof-cream-in-adults-with-plaque-psoriasis-with-durable-on-therapy-and-remittive-off-therapy-benefits/.