Pfizer's JAK1 inhibitor

Today (April 11), the official website of the National Medical Products Administration (NMPA) of China announced that Pfizer`s oral JAK1 inhibitor abrocitinib (abrocitinib, the Chinese brand name is Cipike) has been approved in China. Marketed for adult patients with refractory, moderate-to-severe atopic dermatitis who do not respond well to other systemic treatments (such as hormones or biological agents) or who are not suitable for the above treatments.

Abuxitinib is a once-daily oral JAK1 inhibitor, inhibition of JAK1 is thought to modulate multiple cytokines involved in the pathophysiology of atopic dermatitis, including interleukins IL-4, IL-13, IL- 31. IL-22 and thymic stromal lymphopoietin (TSLP). In September 2021, abroxitinib was approved for the first time in the UK for the treatment of adults and adolescents over 12 years of age with moderate to severe atopic dermatitis, followed by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). The product expresses a positive opinion and recommends its approval for marketing. In the United States, the FDA has accepted the New Drug Application for abrutinib, and has granted the drug breakthrough therapy designation and priority review status for the treatment of patients over 12 years of age with moderate to severe atopic dermatitis.

Previously, abraxitinib tablets have achieved positive results in multiple Phase 3 clinical trials in patients with moderate to severe atopic dermatitis, showing statistically significant improvements in skin symptom clearance, disease severity, and placebo. Compared with the drug, the itching symptoms of the patients were rapidly improved. For example, in a randomized, double-blind, placebo-controlled Phase 3 clinical study called JADE MONO-1, after 12 weeks of treatment, 43.8% and 23.7% of patients in the placebo group had or near complete disappearance (IGA score 0/1), compared with 7.9% in the placebo group. Furthermore, 62.7% and 39.7% of patients in the treatment group, respectively, had a change from baseline in the eczema area and severity index of at least 75% (EASI 75), compared with 11.8% in the placebo group, meeting the trial's main Efficacy endpoint.

According to public information, atopic dermatitis is a chronic skin disease characterized by skin inflammation and skin barrier defects, characterized by red/purpuric spots, pruritus, induration/papules, and oozing/crusting. It is also one of the most common chronic relapsing childhood skin diseases, affecting approximately 10% of adults and approximately 20% of children worldwide. Many patients with moderate to severe disease have poorly controlled disease and require additional treatment options to relieve symptoms.

It is hoped that the approval of Pfizer's abrucitinib tablets in China will bring more treatment options for the corresponding atopic dermatitis patients!