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On February 10, the official website of the China National Medical Products Administration (NMPA) checked the drug registration progress and found that the new drug application for upatinib sustained-release tablets applied by AbbVie has entered: approval, which means that this product is expected to be approved.
Screenshot source: NMPA official website
Discovered and developed by AbbVie scientists, upatinib is a once-daily oral, selective and reversible JAK1 inhibitor
According to public information, upadacitinib (trade name: Rinvoq) was approved by the US FDA as early as August 2019 for the treatment of moderately to severely active rheumatic joints with insufficient response or intolerance to methotrexate inflammatory adult patients
In China, AbbVie submitted two marketing applications for upatinib at the end of 2020, corresponding to two different strengths of 30mg and 15mg
Screenshot source: CDE official website
According to an earlier AbbVie press release, the FDA approved upatinib for the atopic dermatitis indication based on efficacy and safety data provided in a Phase 3 registrational study
Atopic dermatitis is a recurring inflammatory skin disease
It is hoped that AbbVie Upatinib Sustained-Release Tablets will be approved in China as soon as possible, which will provide new treatment options for Chinese patients with atopic dermatitis!
References:
[1] Drug registration progress query on NMPA official website.
[2] U.
[3] RINVOQ® (upadacitinib) Receives FDA Approval for Active Psoriatic Arthritis.