FDA Approves Tapinarof, Psoriasis in Adults

FDA Approves Dermavant’s VTAMA® (tapinarof) cream, 1% for the Treatment of
Plaque Psoriasis in Adults: First Topical Novel Chemical Entity Launched for
Psoriasis in the U.S. in 25 Years

•    Federal regulators have approved a new medication for the treatment of plaque psoriasis in adults.
•    Tapinarof cream 1% is a steroid-free topical cream applied once a day.
•    Experts say the cream provides a non-steroidal alternative for dermatologists to prescribe.
The Food and Drug Administration (FDA) has approved a new topical cream for a type of psoriasis.
Tapinarof cream 1% is a steroid-free topical cream applied once a day. It treats mild, moderate, or severe plaque psoriasis in adults.
“As a dermatologist, I always welcome any new treatment option for my patients with plaque psoriasis. Tapinarof 1% cream is the latest breakthrough – a first in class medication that is entirely different from what is currently available on the market,” said Dr, Brian Toy, an attending dermatologist at Providence Mission Hospital and a clinical professor in the School of Medicine at the University of Southern California.
The FDA based their approval of tapinarof on three phase-three clinical trials, called Psoaring 1, Psoaring 2, and Psoaring 3, an open-label extension study.
About 1,000 adults between 18 and 75 enrolled in Psoaring 1 and Psoaring 2. The participants were randomized to use tapinarof or a placebo for up to 12 weeks. The primary endpoint was to have participants achieve the Physician Global Assessment score of “clear” or “almost clear” and improve at least two grades from their baseline.
At the end of 12 weeks, 36 percent of participants from Psoaring 1 and 40 percent of those from Psoaring 2 reached the primary endpoint, compared to 6 percent of the placebo group.
People taking tapinarof, which is sold under the brand name VTAMA cream, showed a significant improvement in all secondary endpoints versus vehicle from baseline at week 12, including a 75 percent or greater improvement in the Psoriasis Area and Severity Index.
In addition, 73 study participants who achieved the primary outcome continued to Psoaring 3, a 40-week extension study. During this phase, the researchers discontinued treatments. The participants retained their Physicians Global Assessment scores of 0 or 1 for around four months.

Release date : 2022/05/28
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