The first treatment for vitiligo that restores the skin to normal within 24 weeks.

The US Food and Drug Administration (FDA) has approved Opzelura Cream (ruxolitinib) as the first topical treatment for vitiligo in adults and children over 12 years of age.

Opzelura is the first FDA-approved drug for the treatment of repigmentation in patients with vitiligo. Opzelura is applied twice daily to affected areas covering only 10% of the body surface.

A satisfactory patient response may require treatment with Opzelura for more than 24 weeks.

The approval was based on the results of the TRuE-V clinical trial, in which more than 600 randomized patients tested Opzelura or placebo.

In a 24-week trial, 30% of patients treated with Opzelura had a 75% improvement in vitiligo facial area index (F-VASI75) compared with 8-13% of patients treated with placebo. For patients with non-segmental vitiligo, a satisfactory response may require treatment for more than 24 weeks. Approximately half of the patients treated with Opzelur achieved full-face repigmentation at week 52 (F-VASI75).

“There are still no FDA-approved therapies, so the approval of Opzelura is a significant milestone,” David Rosemary, MD, from Tufts Medical Center in Boston, said in a press release for Incyte.

Opzelura is supplied in 60g tubes containing 1.5% ruxolitinib, a drug used to treat moderate to severe myelofibrosis and polycythemia vera, which leads to an overproduction of all types of blood cells.

Notably, non-segmental vitiligo is the most common form of vitiligo. The condition involves loss of pigmentation (depigmentation) in areas of the skin. Depigmentation can occur on the face, neck, and scalp, around body openings such as the mouth and genitals, and in areas that are prone to friction or impact, such as the hands and forearms.

Vitiligo is an autoimmune disease because in people with vitiligo, the immune system attacks the melanocytes in the skin. Many people with vitiligo also have at least one autoimmune disease.

The FDA states that the most common adverse reactions associated with the use of Opzelura include acne and itching at the site of application of the cream, colds, headache, urinary tract infection, redness at the site of application, and fever.

The administration has warned of the dangers of using Opzelura in combination with biopharmaceuticals, JAK inhibitors (drugs that work by inhibiting the activity of one or more enzymes of the Janus kinase family), or strong immunosuppressants such as azathioprine or cyclosporine.

Source: Medical Express + US Food and Drug Administration (FDA)