FDA approves a topical treatment to treat repigmentation in vitiligo in patients 12 and older
Late Monday, the FDA gave the green light to Opzelura, Incyte’s sister JAK inhibitor Jakafi, for nonsegmental vitiligo in adults and adolescents 12 years and older.
The green light makes Opzelura the first FDA-approved treatment for repigmentation in patients with vitiligo.
Additionally, the drug, also known as ruxolitinib cream 1.5%, is the only topical JAK approved in the United States,
Incyte noted in a statement. “Overactivity of the JAK signaling pathway is thought to underlie the inflammation implicated in the pathogenesis and progression of vitiligo,”
Disease or condition
Nonsegmental vitiligo is the most common form of vitiligo.
The condition involves loss of pigment (depigmentation) in patches of skin. Depigmentation can occur on the face, neck, and scalp, and around body openings such as the mouth and genitals, as well as areas that tend to experience friction or shock, such as the hands and arms.
Vitiligo is considered an autoimmune disease. In people with vitiligo, the immune system appears to attack pigment cells (melanocytes) in the skin.
Many people with vitiligo are also affected by at least one other autoimmune disease.
Research Details :-
The FDA approval of vitiligo was based on data from the Phase 3 TRuE-V program, which was conducted in more than 600 patients with nonsegmental vitiligo.
The primary endpoint of the program was the Vitiligo Area Scoring Index (VASI), an indicator of disease severity used by Incyte to measure improvements in repigmentation of the face and body compared to a placebo cream.
Two separate phase 3 studies found that at week 24, approximately 30% of patients who received Opzelura achieved at least a 75% improvement from baseline on the facial vitiligo area scoring index ( F-VASI75), meeting the primary endpoint of the trials.
That compared to 8% and 13% of dummy cream patients in the TRuE-V1 and TRuE-V2 studies, respectively, Incyte said. After one year, approximately 50% of patients taking Opzelura achieved the primary endpoint of facial re-pigmentation.
Safety and Adverse Effects
The most common side effects associated with Opzelura are application site acne, application site itching, colds, headache, urinary tract infection, application site redness and fever.
The use of Opzelura in combination with biological therapeutic agents, other JAK inhibitors or strong immunosuppressants such as azathioprine or cyclosporine is not recommended.
Serious infections, deaths, malignancies, major adverse cardiovascular events and thromboses have been observed in patients treated with JAK inhibitors for inflammatory conditions.