FDA Approves ruxolitinib cream for treatment of Atopic Dermatitis
Written By : Dr Kartikeya Kohli
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2021-09-22 16:00 GMT | Update On 2021-09-22 15:59 GMT
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The US food and drug administration has approved a topical selective Janus kinase (JAK)1/JAK2 inhibitor ruxolitinib (Opzelura) for the treatment of mild to moderate atopic dermatitis.This is a cream for 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 and only topical Janus kinase (JAK) inhibitor approved in the United States.
OPZELURA cream is for use on the skin only. Do not use OPZELURA cream in eyes, mouth or vagina.
The FDA approval was based on data from the TRuE-AD (Topical Ruxolitinib Evaluation in Atopic Dermatitis) clinical trial program, consisting of two randomized, double-blind, vehicle-controlled Phase 3 studies (TRuE-AD1 and TRuE-AD 2) evaluating the safety and efficacy of Opzelura in more than 1,200 adolescents and adults with mild to moderate AD. Results from the studies showed patients experienced significantly clearer skin and itch reduction when treated with Opzelura cream 1.5% twice daily (BID), compared to vehicle (non-medicated cream):
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