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Dermavant publishes positive phase 3 data for treatment of plaque psoriasis

The results were published in the Journal of the American Academy of Dermatology

Dermavant


Dermavant Sciences, a biopharmaceutical company specialising in immuno-dermatology, has shared new data assessing Vtama (tapinarof) 1% cream for the treatment of plaque psoriasis in adults.

The results from the company’s one-year safety and efficacy of the phase 3 PSOARING 3 long-term, open-label extension study were published in the Journal of the American Academy of Dermatology (JAAD) on 26 June 2022.

In May, Dermavant announced that the US Food and Drug Administration (FDA) had granted approval of Vtama 1% cream to treat adults with plaque psoriasis, an approval which meant Vtama cream was the first topical novel chemical cream launched for psoriasis patients in the US in 25 years.

Psoriasis is a chronic, systemic, inflammatory skin condition, affecting an estimated eight million people in the US and 125 million globally. The disease presents in red patches and plaques with silvery scales on the skin, and those with psoriasis are at a risk of developing other chronic and serious health conditions.

The final data published in JAAD underscores efficacy outcomes, quality of life, safety and tolerability assessments observed over patients’ long-term use of Vtama 1% cream. It was found that Vtama cream demonstrated a continued improvement beyond the 12-week double-blind treatment period in the pivotal PSOARING 1 and 2 studies, with up to 41% of patients ultimately achieving complete disease clearance.

Upon achieving complete disease clearance, and patients discontinued using Vtama cream, the mean total duration off therapy before disease worsening was 130 days. The cream has been approved in the US for mild, moderate and severe plaque psoriasis with no limits outlined regarding a duration of use or restrictions for use on body surface.

Commenting on the publication of results, Philip Brown, chief medical officer of Dermavant, said: “We are excited that a journal as prestigious as JAAD has chosen to publish final data from our PSOARING 3 40-week extension efficacy and safety study of Vtama (tapinarof) cream, 1% for adults with plaque psoriasis.

“We were delighted by the FDA’s recent approval of Vtama cream for mild, moderate and severe disease, which we believe can become an improved standard of care for plaque psoriasis patients and their healthcare providers. Vtama cream’s demonstrated combination of efficacy, remittive effect, durability and tolerability make it a strong addition to the psoriasis armamentarium.”

Article by
Fleur Jeffries

29th June 2022

From: Research, Healthcare

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