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USFDA approves topical treatment addressing repigmentation

Opzelura is the first USFDA-approved pharmacologic treatment to address repigmentation in vitiligo patients.

July 25, 2022

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USFDA Drug product Approval — USFDA Approval

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Last Updated on December 31, 2023 by The Health Master

The U.S. Food and Drug Administration (USFDA) has approved Opzelura (ruxolitinib) cream for the treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.

Opzelura is a topical Janus kinase (JAK) inhibitor currently approved for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Opzelura is the first USFDA-approved pharmacologic treatment to address repigmentation in vitiligo patients.

Opzelura is applied twice a day to affected areas of up to 10% of the body’s surface area. A satisfactory patient response may require treatment with Opzelura for more than 24 weeks.

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Disease or Condition

Nonsegmental vitiligo is the most common form of vitiligo. The condition involves loss of pigment (depigmentation) in patches of skin.

Depigmentation may 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 rubbing or impact, such as the hands and arms.

Vitiligo is considered to be an autoimmune disorder. In people with vitiligo, the immune system appears to attack the pigment cells (melanocytes) in the skin. Many people with vitiligo are also affected by at least one other autoimmune disorder.

Effectiveness

The safety and effectiveness of Opzelura were demonstrated in two clinical trials, NCT04052425 and NCT04057573. In both trials, subjects with nonsegmental vitiligo were randomized to treatment with Opzelura or placebo cream twice daily for 24 weeks, followed by an additional 28 weeks of treatment with Opzelura for all subjects.

At the end of the 24-week treatment period, 30% of Opzelura patients had at least 75% improvement in the facial Vitiligo Area Scoring Index, compared with 10% of placebo patients.

Safety Information

The most common adverse reactions associated with Opzelura are application site acne, application site itching, a common cold, headache, urinary tract infection, application site redness, and fever. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.

Serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis have been observed in patients treated with JAK inhibitors for inflammatory conditions.

See full prescribing information for additional information on risks associated with Opzelura.

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