AbbVie’s JAK Inhibitor Upadacitinib Extended-Release Tablets Nearing Approval in China for Moderate-to-Severe Atopic Dermatitis

On February 10, according to the drug registration progress inquiry on the official website of China's National Medical Products Administration (NMPA), the new drug application for AbbVie's upadacitinib sustained-release tablets has entered the "under review" stage, indicating that this product is expected to be approved in China soon. Based on the priority review disclosure by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration, the indication for which upadacitinib sustained-release tablets are expected to gain approval in China is: for adult and adolescent patients aged 12 years and above with moderate to severe atopic dermatitis who are suitable for systemic therapy.

Screenshot source: NMPA official website

Upadacitinib, discovered and developed by AbbVie scientists, 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. They play an important role in the signal cascades of various type I and type II cytokine receptors. The signaling pathways mediated by JAK are related to cell proliferation, differentiation, apoptosis, and inflammation. Among them, JAK1 plays a crucial role in the pathophysiological process of immune-mediated diseases, which makes JAK1 inhibitors potentially capable of treating a variety of diseases.

Public information shows that Upadacitinib (Upadacitinib, trade name: Rinvoq) was first approved for marketing by the U.S. FDA in August 2019 to treat adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to or intolerance to methotrexate. Since then, the drug has been successively approved by the FDA to treat refractory, moderate to severe atopic dermatitis and active psoriatic arthritis in adults and children aged 12 years and above.

In China, AbbVie submitted two marketing applications for upadacitinib in late 2020, corresponding to two different specifications of 30mg and 15mg. The application was subsequently granted priority review by the CDE on the grounds of being "a new type, formulation, or specification of pediatric drug that meets the physiological characteristics of children." The proposed indications are for adult and adolescent patients aged 12 years and older with moderate to severe atopic dermatitis who are suitable for systemic therapy.

Screenshot source: CDE official website

According to an earlier press release by AbbVie, the FDA approval of upadacitinib for the atopic dermatitis indication was based on the efficacy and safety data provided in its Phase 3 registration studies. The program evaluated more than 2,500 patients across three studies (Measure Up 1, Measure Up 2, and AD Up), with approximately 52% of the patients having previously received systemic treatment for atopic dermatitis. The study results showed that both monotherapy with upadacitinib and combination therapy with topical corticosteroids achieved all primary and secondary endpoints at week 16. Compared to the placebo group, some patients in the treatment group achieved higher rates of skin clearance.

Atopic dermatitis is a recurrent inflammatory skin disease. Currently, the treatment status of atopic dermatitis is not satisfactory, especially for moderate to severe atopic dermatitis, both topical and systemic treatments have certain limitations and adverse reactions. With the in-depth research on the pathogenesis of the disease, small molecule targeted inhibitors represented by JAK inhibitors are gradually used in clinical practice, promoting the change of treatment patterns for such diseases.

We hope that AbbVie's Upadacitinib Extended-Release Tablets will be approved in China as soon as possible, allowing Chinese patients with atopic dermatitis to have a new treatment option!

References:

[1] NMPA Official Website Drug Registration Progress Inquiry. Retrieved Feb 10, 2022, from http://sq.nmpa.gov.cn/datasearch_nmpa/schedule/search.jsp?

[2] U.S. FDA Approves RINVOQ® (upadacitinib) for the Treatment of Adults and Children Aged 12 Years and Older with Refractory, Moderate to Severe Atopic Dermatitis. Retrieved Jan 17, 2022, from https://mp.weixin.qq.com/s/0Z1sh2ezipuljymQD3yxBw

[3] RINVOQ® (upadacitinib) Receives U.S. FDA Approval for the Treatment of Active Psoriatic Arthritis. Retrieved Dec 16, 2021, from https://mp.weixin.qq.com/s/ofMsIhKj6wecqCxq7QL6cA

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