Recently, the FDA approved Incyte’s JAK inhibitor Rucotinib Cream (Opzelura) for short-term and non-continuous long-term treatment of non-immune-compromised patients with mild to moderate atopic dermatitis and Opzelura became FDA approved. The first and only topical JAK inhibitor.

What is AD?

Atopic dermatitis (AD), also known as atopic eczema, is a special type of eczema and one of the most common chronic inflammatory skin diseases, affecting people of all ages and genders worldwide. The symptoms of AD are rash (or recurrent skin lesions), causing itching, and may be relieved or recurred or attacked over time, and can also lead to sleep disturbance, embarrassment, and inattention.

The pathogenic mechanism of atopic dermatitis has not yet been fully clarified, but the most recognized hypothesis is abnormal inflammation of the immune system. Various factors lead to impaired skin barrier of patients. After the patient is exposed to allergens, the abnormal immune response driven by type 2 helper T cells is activated. Many factors such as genetic susceptibility and skin microbes play a role in this process.

The first topical JAK inhibitor approved by the FDA

Opzelura is a patented formulation of ruxolitinib, a selective JAK tyrosine kinase reversible inhibitor developed by Incyte, designed for topical application.

Rucotinib can competitively bind with ATP at the catalytic site of the enzyme, and down-regulate the abnormally activated signal pathway, so as to achieve the purpose of treatment. The JAK protein kinase family plays an important role in mediating the signal transmission of inflammatory cytokines. It can quickly control itching and eliminate inflammation faster than traditional biological agents.

Opzelura is currently developing the treatment of vitiligo and alopecia areata, and the research on the treatment of vitiligo has entered the third clinical phase.

Jakavi, an oral tablet of rucotinib developed by Incyte, was approved by the FDA in November 2011. It can currently be used for the treatment of myelofibrosis, thrombocythemia, polycythemia vera and graft-versus-host disease; A new indication was approved for chronic graft-versus-host disease after failure of first-line or second-line systemic therapy for adults and children 12 years and older. Jakavi has now entered the heavyweight ranks, with global sales in 2020 reaching 3.276.8 billion U.S. dollars.