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Dermavant’s Vtama receives FDA approval for plaque psoriasis

It is the first topical steroid-free cream to be granted FDA approval in its class

Dermavant


Dermavant Sciences’ Vtama (tapinarof) has been approved by the US Food and Drug Administration (FDA) to treat plaque psoriasis in adults. The 1% cream is the first and only FDA-approved steroid-free topical medication in its class.

In the phase 3 clinical trial, Vtama cream met all primary and secondary endpoints and showed a statistically significant improvement. Patients in the study who had clear or almost clear skin after three months of using the cream still had clear or almost clear skin four months after stopping the treatment.

Safety and tolerability levels were consistent across all three trials (PSOARING 1, 2 and the phase 3 long-term extension (LTE) study), with most of the adverse events being localised and described as ‘mild to moderate’.

Todd Zavodnick, CEO of Dermavant, said: “We are delighted with our FDA-approved label for Vtama cream, which is for adults with psoriasis, regardless of disease severity, and with an unlimited duration of use.”

He added: “As the first and only approved drug in its class in the US, the FDA’s approval of Vtama cream provides an effective new non-steroidal treatment option for millions of adults living with plaque psoriasis.”

Patients involved in the trial were asked to fill out a questionnaire and responses were evaluated once the phase 3 study was completed. The survey showed high levels of satisfaction with the treatment, with 85.8% of patients surveyed from the phase 3 LTE study saying that they could easily manage their psoriasis with Vtama cream.

Additionally, 81.7% of patients felt Vtama is more effective than previously used topical treatments, with the majority of patients agreeing that the cream had fast absorption, felt good on their skin and was not greasy.

Vtama has been approved for mild, moderate and severe psoriasis and has an unlimited duration of use. Dermavant is preparing to launch the product in June 2022.

Article by
Fleur Jeffries

27th May 2022

From: Research, Regulatory, Healthcare

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