FDA Approves Opzelura (Ruxolitinib) Cream for Vitiligo in Patients Aged 12 Years and Older

On July 19, 2022, the FDA approved Opzelura (ruxolitinib), the first and only topical treatment for non-segmental vitiligo in adult and pediatric patients aged 12 years and older.

Opzelura (ruxolitinib cream) is a topical Janus kinase (JAK) inhibitor currently authorized for the topical short-term and non-continuous chronic treatment of mild-moderate atopic dermatitis in non-immunocompromised patients aged 12 years and older, whose condition is not adequately controlled with topical treatments or when those treatments are not advisable.

This first FDA-approved pharmacologic therapy to address repigmentation in patients with Vitiligo should be applied twice daily to affected areas of up to 10% of the body’s surface area. Acceptable patient response may require treatment with this medicinal product for more than 24 weeks.

What Is Vitiligo?

Vitiligo is an autoimmune disorder that typically causes patches of skin to lose pigmentation or color. When the immune system attacks melanocytes; skin cells that make a pigment known as melanin; it causes the skin to turn milky-white in color.

Nonsegmental vitiligo is the most common type and can affect anyone regardless of their age, sex or ethnicity. This form of vitiligo occurs in white patches symmetrically on both sides of the body. It can also emerge on the face, mouth, legs, neck, scalp, arms, and genitals. 

Safety and Effectiveness:

The safety and effectiveness of Opzelura (ruxolitinib) were demonstrated in two carried out clinical trials addresses as NCT04052425 and NCT04057573.

In both trials, subjects with nonsegmental vitiligo were randomized to treatment with Opzelura (ruxolitinib) or placebo cream twice daily for 24 weeks, followed by an additional 28 weeks of treatment with Opzelura (ruxolitinib) for all subjects. After the treatment of 24-week, 30% of Opzelura patients had at least 75% recovery, compared with 10% of placebo patients.

Safety Information:

The most commonly reported side effects of Opzelura are common cold, headache, urinary tract infection, fever, and application site itching, acne, and redness. Use of this cream along with therapeutic biologics, certain other JAK inhibitors, or potent immunosuppressants such as cyclosporine or azathioprine is not recommended.

Severe infections, malignancy, mortality, major adverse cardiovascular events, and thrombosis have been seen in patients treated with Janus kinase (JAK) inhibitors for inflammatory conditions.

Reference:

https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-topical-treatment-addressing-repigmentation-vitiligo-patients-aged-12-and-older