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.
Recently approved in China
According to the priority review announcement of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China, the indications for Upadatinib Sustained-Release Tablets to be approved in China are: adults and adults 12 years old and 12 years old who are suitable for systemic therapy.
Moderate to severe atopic dermatitis in adolescents and adolescents
Screenshot source: NMPA official website
Discovered and developed by AbbVie scientists, upatinib is a once-daily oral, selective and reversible JAK1 inhibitor
The JAK family is a class of non-receptor tyrosine kinases, including four subtypes, JAK1, JAK2, JAK3, and TYK2, which play important roles in the signaling cascades of various type I and type II cytokine receptors.
JAK-mediated signaling pathways are related to cell proliferation, differentiation, apoptosis, and inflammation
Among them, JAK1 plays an important role in the pathophysiology of immune-mediated diseases, which makes JAK1 inhibitors have the potential to treat a variety of diseases
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
The drug has since been approved by the FDA for the treatment of refractory, moderate-to-severe atopic dermatitis and active psoriatic arthritis in adults and children and adolescents 12 years of age and older
In China, AbbVie submitted two marketing applications for upatinib at the end of 2020, corresponding to two different strengths of 30mg and 15mg
The application was subsequently included in priority review by CDE on the grounds of "new varieties, dosage forms and specifications of children's medicines that meet the physiological characteristics of children".
Patients with moderate to severe atopic dermatitis
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
The project evaluated more than 2,500 patients across 3 studies (Measure Up 1, Measure Up 2, and AD Up), and approximately 52% of patients had received prior treatment for systemic atopic dermatitis
Results of the study showed that upatinib alone and in combination with topical glucocorticoids met all primary and secondary endpoints at week 16
Some patients in the treatment group achieved higher skin clearance rates than in the placebo group
Atopic dermatitis is a recurring inflammatory skin disease
At present, the current status of the treatment of atopic dermatitis is not satisfactory, especially in the treatment of moderate to severe atopic dermatitis, both topical and systemic treatment have certain limitations and adverse reactions
With the in-depth study of the pathogenesis of the disease, small molecule targeted inhibitors represented by JAK inhibitors are gradually used in the clinic, which has promoted the change of the treatment mode of such diseases
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!
 Drug registration progress query on NMPA official website.
Retrieved Feb 10, 2022, from http://sq.
FDA approves RINVOQ® (upadacitinib) for the treatment of refractory, moderate-to-severe atopic dermatitis in adults and children and adolescents 12 years and older.
Retrieved Jan 17 2022 , from https://mp.
 RINVOQ® (upadacitinib) Receives FDA Approval for Active Psoriatic Arthritis.
Retrieved Dec 16, 2021 , from https://mp.