Dermavant looks to dethrone topical steroids with first FDA approval for Vtama in psoriasis

Psoriasis newcomer tapinarof could be as big for dermatology as the pivot from analog cassettes to high-quality digital streaming. That’s according to Dermavant CEO Todd Zavodnick, who sat down virtually with Fierce Pharma ahead of the company’s “game-changer” approval Tuesday.

The U.S. FDA has given tapinarof the green light in adults with plaque psoriasis—a complex autoimmune disease that affects some 8 million Americans and 125 million people globally. Now christened Vtama cream, 1%, the aryl hydrocarbon receptor agonist is the first steroid-free topical therapy in its class, and it’s poised to become the first unique topical launched for psoriasis in 25 years, Dermavant said in a release.

The company isn’t mincing words about its ambitions for the new drug, its first-ever approval, either.

“We’re moving to the next generation where dermatology has been a little bit behind, and we’re going to be replacing the standard of care,” Zavodnick said in an interview.

That current standard is steroids, which come with plenty of limitations, the helmsman added.

“They thin the skin; they have impacts on the body internally; they can’t be used on sensitive areas at all,” Zavodnick said.

Crucially, “there’s massive limitation for length of time [steroids] can be used,” the CEO added.

Vtama, for its part, is a once daily, “cosmetically elegant” cream that can be used “anywhere on the body for any length of time, with no warnings or safety precautions,” the CEO said.

Psoriasis is classed as mild, moderate or severe according to the percentage of body surface area affected, and Vtama’s label covers the full spectrum of disease.

Dermavant believes its new drug could represent the “mainstay, first-line therapy” for psoriatic disease, Zavodnick said. “We believe [Vtama] will be first-line for mild to moderate treatment, no doubt.”

It's been quite the journey for the drug. Originally developed by GSK, Dermavant, part of the Roivant cluster of biotechs, licensed the med from the U.K. Big Pharma back in 2018 for $330 million and took it through its phase 3 to today's approval. 

Steroids aside, the psoriasis arena is crowded with Big Pharma biologics like AbbVie’s megablockbuster Humira and Johnson & Johnson’s Remicade, plus oral options like Amgen’s Otezla. Vtama, as a cream that can be applied directly to affected areas, has the potential to complement—rather than compete with—systemic therapies, the CEO explained.

But Dermavant already has topical rivals waiting in the wings. Arcutis Biotherapeutics is also anticipating an FDA decision this year—July 29, to be exact—for its hopeful ARQ-151, a topical formulation of the PDE4 inhibitor found in AstraZeneca’s chronic obstructive pulmonary disease treatment Daliresp.

Dermavant is still bullish, and its own research has shown 66% of psoriatic patients that get a systemic treatment also receive a “concomitant topical to treat spot disease where the systemic doesn’t fully get them coverage,” Zavodnick said. Dermavant believes Vtama will fill that niche.

In the med’s pivotal PSOARING 1 and PSOARING 2 studies, Vtama helped a statistically significant number of patients reach scores of “clear” or “almost clear” on a physician assessment of disease severity versus a dummy cream at week 12. The drug aced all its secondary endpoints, as well, Dermavant said. Those included a more than 75% improvement in the Psoriasis Area and Severity Index (PASI) from baseline over the same period.

Patients who completed PSOARING 1 or 2 could then take part in PSOARING 3, which consisted of 40 weeks of open-label treatment with the drug followed by a four-week follow-up, the company explained.

Some 92% of patients that finished the pivotal trial at 12 weeks elected to roll over to the long-term safety study, Zavodnick pointed out. “Ninety-two-percent of patients voted to stay on Vtama for the full 52 weeks; they wanted the drug.”

Crucially, in that study, Vtama charted impressive remission stats. Patients saw a median duration of clear or almost clear skin of approximately four months after stopping treatment with Dermavant's cream.

That's a major improvement over the 30 days to flare patients experience on topical steroids, Zavodnick said.

Further, patients' interest in the long-term study comes as a big vote of confidence for Dermavant’s med, Zavodnick figures, given the myriad psoriasis treatment options already on tap.

Vtama isn’t stopping at psoriasis, either. In September, Dermavant started dosing patients with tapinarof cream in a phase 3 study of kids and adults with atopic dermatitis, and it expects to have top-line results from that trial by the first half of 2023, Zavodnick said.

“We’re going to replace the standard of care for immuno-dermatology,” which requires that you deliver on both the psoriasis and eczema fronts, Zavodnick pointed out.

If approved in eczema, Vtama would become the first non-steroidal topical to span both diseases, Zavodnick said. 

Meanwhile, Dermavant is primed and ready for Vtama’s June launch. The company has completed product and sample manufacturing runs, and its commercial organization is “100% built out and ready to enter the marketplace,” Zavodnick said.

“Approval doesn’t always mean launch, but it does for Dermavant,” he added.

Jefferies wrote in a recent note to clients that it sees tapinarof revenue this year hitting $10 million at the high end and ramping up to $50 million in 2023 for its psoriasis label.