Beijing News (Reporter Yue Qingxiu) On February 24, the official website of the State Food and Drug Administration showed that AbbVie’s innovative immune drug Ruifu (upatinib sustained-release tablets) was approved for marketing, which is suitable for other systems. Adults and adolescents 12 years of age and older with refractory, moderate-to-severe atopic dermatitis who do not respond well to or are inappropriate to treatment (eg, hormones or biologics).
Upatinib sustained-release tablets, discovered and developed by AbbVie, is the first oral selective JAK inhibitor approved for atopic dermatitis in my country. The starting dose is 15 mg once daily in pediatric and adolescent and adult patients 12 years of age and older weighing 40 kg or greater; in children and adolescents with poor response and adults under 65 years of age, the dose may be increased to 30mg once a day.
Atopic dermatitis is a chronic, relapsing inflammatory disease in which repeated intense itching and scratching can lead to cracked, scaly, and oozing skin. It is estimated that the prevalence rate of atopic dermatitis in China is 2460.18/100000, and the number of patients has increased by more than 25% in recent decades. The prevalence rates of adults and adolescents in my country are about 4.6% and 2.5%, respectively.
“Atopic dermatitis seriously affects the daily life of patients and reduces the quality of life of patients. The efficacy of existing systemic drugs is still unsatisfactory. As a treatment for moderate to severe atopic dermatitis, Oral JAK inhibitors, upatinib extended-release tablets provide more options for the treatment of patients with atopic dermatitis.” Professor Zhang Jianzhong, director of the Department of Dermatology, Peking University People’s Hospital, said.
Professor Zheng Min, chief physician of dermatology at Zhejiang University School of Medicine, also said: “In January this year, the U.S. Food and Drug Administration (FDA) just approved upatinib sustained-release tablets for the treatment of moderate-to-severe special cases. Atopic dermatitis patients. Based on the same global Phase 3 registration study, Upadatinib Sustained-Release Tablets received priority review and accelerated approval in China. This not only basically achieved the global simultaneous approval of the new JAK inhibitor, but also allowed China Patients can benefit simultaneously.”
It is reported that Refu (upatinib extended-release tablets) is used in the treatment of atopic dermatitis (long-term extension study) and psoriatic arthritis (long-term extension study) in China , Crohn’s disease, ulcerative colitis and axial spondyloarthritis phase III studies are also underway.
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