FDA sets April date for verdict on Incyte's vitiligo drug

Incyte could be a few month away from a second FDA approval for its Opzelura cream that would make it the first medical treatment to re-pigment the skin of people with vitiligo.

The FDA has kicked off a priority review of Opzelura (ruxolitinib), a JAK1/JAK2 inhibitor it approved to treat atopic dermatitis in September, and aims to decide on the vitiligo indication by 18 April next year.

If approved, Opzelura would provide an alternative to steroid drugs currently used to treat vitiligo, a chronic autoimmune disease that causes depigmentation of skin and affects around 1.5 million people in the US.

Results in vitiligo came from the TRuE-V1 and TRuE-V2 studies, which showed that around 30% of patients treated with ruxolitinib cream twice daily achieved 75% or more improvement from baseline in the facial vitiligo area scoring index at 24 weeks, significantly more than in a control group.

The studies, which each enrolled around 300 adolescents and adults aged 12 years and older with vitiligo, also met secondary endpoints including improvements in patient reported outcomes. 52-week data is expected in the coming weeks.

Opzelura is a topical version of Incyte's oral drug Jakafi/Jakavi, which is FDA approved for myelofibrosis, polycythaemia vera and graft-versus-host-disease, and has been billed as a major growth driver for the company.

The rollout in atopic dermatitis has been hit by a few teething troubles relating to manufacturing quality, but have been resolved and Incyte is anticipating peak US sales of $1.5 billion in this indication alone.

Opzelura was cleared by the FDA with a black box warning that includes JAK class-wide wording for risks such as infections, heart-related events and cancer, despite being used on the skin rather than administered systemically.

Incyre's general manager for North America said on the company's third-quarter results last month that Opzelura would be a "game changer" for people with vitiligo and will "help maybe hundreds of thousands of patients, if not more, live a better life."

If that prediction is correct the new indication could provide an upside to peak sales projections for the franchise, not least because patient with vitiligo have to use more tubes of Opzelura over the course of treatment, at around 10 per year versus three for atopic dermatitis.

Incyte has also filed for approval of Opzelura as a treatment for vitiligo in Europe, with a decision also due in 2022.

The company is also developing an oral JAK inhibitor - INCB54707 – that could be an option for people with more extensive vitiligo and is currently in phase 2 trials in people with total body surface area involvement of 8% or more.

Photo by Hanen BOUBAHRI on Unsplash