Incyte preps second filing for ruxolitinib cream after vitiligo trial win
Incyte has made further progress with its ruxolitinib cream, notching up a phase 3 trial showing it can re-pigment skin in vitiligo ahead of a key FDA decision in atopic dermatitis.
Ruxolitinib is a topical Janus kinase (JAK) inhibitor that could provide an alternative to the steroids commonly used to treat these skin conditions, although these drugs have some undesirable side-effects.
It’s the same active ingredient that is used in Incyte/Novartis Jakafi/Jakavi, which is FDA approved in oral form for myelofibrosis, polycythemia vera and graft-versus-host-disease.
However in the topical formulation Incyte holds global rights, meaning success in dermatology indications could generate significant new income for the Delaware-based pharma.
Results in vitiligo came from the TRuE-V1 and TRuE-V2 studies, which showed that significantly more patients treated with ruxolitinib cream twice daily achieved 75% or more improvement from baseline in the facial vitiligo area scoring index compared with 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 patient reported outcomes.
The long-term efficacy and safety portions of both studies will continue as planned and data will be presented at an upcoming scientific meeting in the second half of 2021.
Filings with the FDA and the European Medicines Agency are planned for the second half of this year.
The FDA is reviewing data from ruxolitinib cream for atopic dermatitis, also known as eczema, and a decision is due on or before 21 June following a faster Priority Review.
Vitiligo is a chronic autoimmune disease characterised by depigmentation of skin that results from the loss of pigment-producing cells known as melanocytes.
Over-activity of the JAK signalling pathway has been shown to drive the inflammation that causes vitiligo and drives its progression.
Aside from vitiligo and eczema, Incyte is also developing the cream as a treatment for hidradenitis suppurativa, another immune-related skin condition that causes abscesses and scarring.
Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.