2023-03-15| Trials & Approvals

Dermavant Eyes Second Vtama Indication with Topline Atopic Dermatitis Results

by Reed Slater
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After gaining FDA approval in May last year to treat plaque psoriasis in adults, Dermavant recently announced positive Phase 3 trial results for its topical skin treatment, Vtama, evaluating the safety and efficacy of treating atopic dermatitis. If all goes well, Vtama could be a leading contender to Incyte’s newly-approved Opzelura in the atopic dermatitis arena. 

Competition in the Atopic Dermatitis Field

Atopic dermatitis, commonly called eczema, is one of the most common skin conditions in the world. Over 26 million people in the U.S. deal with the condition at any given time, prompting the constant need for more effective therapies to treat the ailment.

Dermavant designed Vtama as an aryl hydrocarbon receptor agonist and has already gained FDA approval to treat adults with plaque psoriasis. Now, the company is targeting its second indication for Vtama to compete with Incyte’s Opzelura. 

A key difference between Opzelura and Vtama is their mechanism of action. Incyte designed Opzelura as a Janus kinase (JAK) inhibitor, which prompted an FDA warning on its packaging. According to the FDA, JAK inhibitors can increase the risk of heart-related events, cancer, blood clots, and even death. 

Despite the concern, Opzelura, which the FDA approved in 2021 to treat atopic dermatitis, has done tremendously well on the market. The drug even went on to gain approval to treat vitiligo.

Dermavant is biting at Opzelura’s heels with Vtama, though, with some promising results from its Phase 3 ADORING 2 Trial. 

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ADORING 2’s Optimistic Results

Seeing Vtama’s potential to treat atopic dermatitis across age ranges, Dermavant chose to include adult and pediatric patients in the ADORING 2 trial. Dermavant randomized the participants in a two-to-one ratio to receive Vtama or vehicle cream. 

The study accomplished its primary endpoint by clearing or almost clearing atopic dermatitis in 46.4% of participants after eight weeks. Additionally, Vtama cleared at least 75% of atopic dermatitis in 59.1% of the participants, accomplishing the secondary endpoint. 

Because Dermavant intends to market Vtama for use in children as young as two years old, the company highlighted the product’s safety, declaring that there are no serious safety or tolerability issues associated with the therapy. 

With some positive results bolstering Vtama’s position as a potential atopic dermatitis treatment, Incyte might have reason to worry about the future success of Opzelura. Until then, Dermavant will continue bringing in revenue from Vtama’s current indication, treating adults with plaque psoriasis. 

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