Opzelura FDA Approval History
Last updated by Judith Stewart, BPharm on July 20, 2022.
FDA Approved: Yes (First approved September 21, 2021)
Brand name: Opzelura
Generic name: ruxolitinib
Dosage form: Cream
Company: Incyte Corporation
Treatment for: Atopic Dermatitis, Vitiligo
Opzelura (ruxolitinib) cream is a topical Janus kinase (JAK) inhibitor used for the treatment of atopic dermatitis and nonsegmental vitiligo.
- Opzelura is indicated for:
- the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) 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.
- the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.
- Opzelura (ruxolitinib) is the first and only topical Janus kinase (JAK) inhibitor approved for use in the United States. The oral formulation of ruxolitinib was first approved under the brand name Jakafi in 2011 and is used for the treatment of myelofibrosis, polycythemia vera, and graft-versus-host disease.
- Over-activity of the JAK signaling pathway has been shown to drive inflammation in atopic dermatitis and vitiligo. Opzelura works to reduce inflammation by inhibiting JAK.
- Opzelura is administered topically. Patients should not use more than one 60 gram tube per week or one 100 gram tube per 2 weeks.
- Atopic Dermatitis: Opzelura is administered by applying a thin layer twice daily to affected areas of up to 20% of the body surface area.
- Nonsegmental Vitiligo: Opzelura is administered by applying a thin layer twice daily to affected areas of up to 10% body surface area.
- Warnings and precautions associated with Opzelura include serious infections; non-melanoma skin cancers; thrombosis; and thrombocytopenia, anemia and neutropenia. The Opzelura product label carries a boxed warning for serious infections leading to hospitalization or death; higher rate of all-cause mortality, including sudden cardiovascular death; lymphoma and other malignancies; higher rate of major adverse cardiovascular events (including cardiovascular death, myocardial infarction, and stroke); and thrombosis (including deep venous thrombosis, pulmonary embolism, and arterial thrombosis).
- Common adverse reactions in atopic dermatitis patients include nasopharyngitis, diarrhea, bronchitis, ear infection, eosinophil count increased, urticaria, folliculitis, tonsillitis, and rhinorrhea. Common adverse reactions in nonsegmental vitiligo patients include application site acne, application site pruritus, nasopharyngitis, headache, urinary tract infection, application site erythema, and pyrexia.
Development timeline for Opzelura
Further information
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