Ruxolitinib (sold under the brand names Jakafi and Jakavi among others, and as Opzelura in cream form) is a medication used for the treatment of intermediate or high-risk myelofibrosis,[6] a type of myeloproliferative neoplasm that affects the bone marrow;[11][12] polycythemia vera, when there has been an inadequate response to or intolerance of hydroxyurea;[6][13] and steroid-refractory acute graft-versus-host disease.
[citation needed] In the United States, ruxolitinib cream is indicated for the topical treatment of mild to moderate atopic dermatitis and vitiligo.
[7] In the European Union, ruxolitinib cream is indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.
[6] In March 2012, the phase III Controlled Myelofibrosis Study with Oral JAK Inhibitor-I (COMFORT-I) and COMFORT-II trials showed significant benefits by reducing spleen size and relieving debilitating symptoms.
[23][24][25][26] In November 2011, ruxolitinib was approved by the U.S. Food and Drug Administration (FDA)[15] for the treatment of intermediate or high-risk myelofibrosis based on results of the COMFORT-I and COMFORT-II Trials.
[29] The indication was further expanded in the US in September 2021, for the treatment of chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in people 12 years of age and older.
[30] In September 2021, ruxolitinib cream (sold under the brand name Opzelura) was approved for medical use in the United States[31] for the treatment of mild to moderate atopic dermatitis (AD).