This year’s American Academy of Dermatology (AAD) Annual Meeting is already in full swing in Boston, and all eyes will be on Incyte tomorrow as it reveals details on two Phase III trials studying its JAK1/JAK2 inhibitor ruxolitinib cream for vitiligo.

To recap, the FDA extended its review of ruxolitinib in vitiligo for three months from 18 April to 18 July. The agency requested to review additional data from the Phase III trials, characterising the absence of this information as a “major amendment” to the company’s application for vitiligo.

A potential expansion to vitiligo is key for Incyte. Ruxolitinib is currently available for atopic dermatitis under the brand name Opzelura. According to forecasts, vitiligo patients are more likely to use more tubes of the cream annually at approximately 10 tubes per year, in comparison to three tubes per year for atopic dermatitis.

A similar delay happened when the company sought FDA approval for the cream in atopic dermatitis, with the agency also requesting additional information leading to a three-month delay on its PDUFA date. On September 2021, Opzelura eventually received FDA approval in the mild-to-moderate setting in patients 12 years old and over.

Available ruxolitinib data so far in vitiligo

Both Phase III trials in vitiligo, dubbed TRuE-V1 (NCT04052425) and TRuV2 (NCT04057573), recruited some 600 adolescent and adult participants with nonsegmental vitiligo. The company has so far announced that both trials met their primary endpoints, such as achieving a 75% improvement from baseline in the facial vitiligo area scoring index, versus patients treated with a vehicle control at week 24. The most recent findings will be presented at AAD this weekend, as per the session schedule.

According to GlobalData, global sales for Opzelura are expected to rise from $5m in 2021 to $108m in 2022 in all indications, highlighting a significant increase in sales due to the potential label expansion. Peak sales are expected to reach $842m in 2028. Ruxolitinib is currently under development for additional indications including pruritus and discoid lupus erythematosus.

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There are currently no available approved therapies in the US for vitiligo. Vitiligo is a chronic immune-mediated dermatological condition that results in pale white patch formation on the skin, due to loss of pigmentation (melanin) in the skin. Commonly affected areas include the face, neck, and hands.