With topical approval, Dermavant looks to bring new standard-of-care to plaque psoriasis patients
Dermavant CEO Todd Zavodnick has been plotting to upend the plaque psoriasis market for years now. And with the company’s first approval on Tuesday, he’s pulling the trigger.
The FDA on Tuesday approved Dermavant’s “cosmetically elegant” vanishing cream tapinarof, the first steroid-free topical medication in its class, now marketed as Vtama. And unlike other launches, which could take months, Zavodnick is ready to roll it out as early as next week.
“Approval doesn’t mean launch. But it does when you have a team that’s this ready and that’s put as much time as we have into this preparation, and our focus in making sure that we are day one ready to have approval equal launch,” he said.
Vtama’s website was live on Tuesday morning, advertising that patients with commercial insurance may be able to get the once-daily cream with no out-of-pocket cost, while those who are uninsured may pay as low as $75.
Zavodnick has a distinct commercial plan in mind for Vtama, as the highly competitive plaque psoriasis market is already ruled by blockbuster drugs such as Stelara, Skyrizi and Cosentyx. He sees Vtama as a replacement for steroids in the topical space while leaving the most severe cases to the ultra-effective biologics, where he says the cream could act as an add-on therapy.
The cream can be used “anywhere on the body for any length of time,” with no safety warnings on the label. That’s the antithesis of most steroidals, which can’t be used for more than two to four weeks and can’t be used on sensitive areas, Zavodnick said.
He compared the difference to cassette tapes versus digital music, adding that Vtama could “leapfrog dermatology to the next step on the horizon.”
“I think it’s going to be used first-line where physicians will move away from steroids to Vtama. And then I think for patients that have larger body surface area, where they may be on a systemic, again, we know two-thirds of those patients are getting topicals, and Vtama would be the perfect partner,” he said.
Tapinarof, an aryl hydrocarbon receptor agonist, was plucked from GSK by Vivek Ramaswamy’s team back in 2018 for $330 million — $200 million upfront. In two Phase III trials, dubbed PSOARING 1 and 2, the drug demonstrated significant improvements in Physician Global Assessment score, with patients seeing a minimum 2-grade improvement compared to placebo at week 12.
Last April, Zavodnick revealed at the American Academy of Dermatology virtual meeting that around 20% of moderate to severe plaque psoriasis patients given tapinarof in two Phase III trials achieved 90% disease clearance, measured by the Psoriasis Area and Severity Index (PASI 90) at Week 12. And around 67% and 60% of patients in the trials felt itch relief starting as early as Week 2.
“We don’t talk PASI 90s with topicals,” he told Endpoints News at the time. “We talk PASI 90s with an oral or an injectable.”
In a long-term extension study, over 40% of patients achieved complete disease clearance (PGA=0) at least once.
The most common adverse reactions, according to the label, were folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and the flu.
Looking ahead, a fully built team of about 150 people will soon launch a campaign that “will blanket the United States in a way that will ensure every dermatologist and suffering psoriatic patient is completely aware of Vtama immediately,” Zavodnick said, while keeping quiet on the details.
“When patients are clear and they stop … it’s a big deal because they’re remaining clear for a median of up to four months, and so for us, that’s remarkable to share,” Zavodnick said.
But he isn’t stopping there. Last year, Dermavant launched a Phase III program for tapinarof in atopic dermatitis, which will read out the first results in the first half of next year.
