Dermavant plans to file Vtama for FDA approval after positive results in itchy skin condition

Dermavant eyes FDA nod for Vtama in itch relief

Dermavant is advancing in the race to develop nonsteroidal topical treatments for autoimmune skin conditions, building on its FDA approval of Vtama for plaque psoriasis last year. The company has presented data at the European Academy of Dermatology and Venereology Congress, showcasing Vtama’s potential to provide immediate and sustained relief from pruritus, a severe itch common in atopic dermatitis (eczema).

In two phase 3 trials involving over 400 patients each, Vtama demonstrated notable reductions in Peak Pruritus Numerical Rating Scale scores compared to a placebo vehicle. These reductions were observed as early as Day 1 in one trial and Day 2 in the other. The improvements in daily pruritus scores extended through Week 2 and up to Week 8 in both trials.

Also Read: Evommune Abandons EVO101, A Topical IRAK4 Inhibitor, For Atopic Dermatitis

Armed with these compelling results, Dermavant intends to seek FDA approval for the treatment of atopic dermatitis in adults and children as young as 2 years old. If granted, this would make Vtama the first nonsteroidal treatment for both plaque psoriasis and eczema.

Dermavant acquired Vtama, an aryl hydrocarbon receptor agonist, from GSK in 2018 for $330 million. Vtama received its initial approval in May of the preceding year and has generated $17 million in sales during the second quarter of this year.

Vtama’s unique value lies in its compatibility with systemic therapies like AbbVie’s Humira, Amgen’s Otezla, and Johnson & Johnson’s Remicade.

It’s important to note that nonsteroidal competition exists in the topical treatment market, with Arcutis Biotherapeutics securing approval for Zoryve in plaque psoriasis last year. Arcutis envisions significant sales potential across multiple indications, with estimates reaching up to $3.8 billion.

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