AbbVie JAK1 inhibitor listing applications are to be included in the priority review

Transfer from | According to the latest announcement by the Drug Review Center (CDE) of the State Drug Administration of China, two listing applications for AbbVie's JAK inhibitor Upadacitinib are to be included in the priority review, with the proposed development of adaptive disorders for adults with systemic treatment and severe specialty dermatitis patients in adults aged 12 and over.
according to CDE publicity, the two listing applications corresponding to 30mg and 15mg two different specifications.
screenshot source: CDE website Upatini was discovered and developed by AbbVie scientists and is a daily oral, selective and reversible JAK1 inhibitor.
JAK1 play an important role in the pathophysiology of immuno-mediated diseases.
August 2019, it was approved by the U.S. FDA to treat adult patients with moderate to severe active rheumatoid arthritis who did not respond to or were insatiable with methotrexate.
also received FDA breakthrough therapy in 2018 for adult patients with moderate to severe endexual dermatitis who are suitable for systemic treatment.
In June 2020, Upatini as a monotherapy in the treatment of patients with moderate to severe endotopic dermatitis reached a common primary endpoint in a key Phase 3 clinical trial called Metasure up 1, significantly reducing skin symptoms in patients.
specifically, there was a significant improvement in the removal rate of skin symptoms in patients treated with 15 mg or 30 mg of Upatini monotherapy, with 70% and 80% of patients reaching EASI 75 (at least 75% improvement in eczema area severity index) at the 16th week of treatment (vs 16%).
using vIGA scores, 48/62% of patients treated with uppatinib (15/30 mg) scored 0 (skin symptoms completely cleared) or 1 (skin symptoms were almost completely cleared), compared with 8% in the placebo group.
In July 2020, Upatini was used in association with external corticosteroids (TCS) to achieve a common primary and all secondary endpoints in AD Up, a critical Phase 3 clinical trial for the treatment of moderate-to-severe idiotopic dermatitis.
results showed that more patients in the patient group who received any dose of uppatinib-TCS achieved significant improvement in skin symptoms in week 16 than in placebo-TCS.
65 per cent and 77 per cent of patients treated with Upatini (15/30 mg) and TCS met the EASI 75 standard (vs 26 per cent), respectively.
40%/59% of patients treated with upatinib (15/30 mg) and TCS scored vIGA-AD, respectively, with a score of 0 or 1, and 11% in the placebo group.
the main efficacy results of the trial (Photo: Reference: References) In December 2020, Upatini has achieved positive results in Phase 3 clinical trial Head up for the treatment of specific dermatitis: receiving upatini (30 mg daily oral) After 16 weeks, 71% of adult-specific dermatitis patients with moderate to severe eczema area improved by 75% or more (EASI 75), which was better than the control group (61%) treated with the controlled drug dupilumab, reaching the main endpoint of the trial.
addition, uppardinists showed better results than controlled drugs at secondary endpoints such as itching and skin removal.
phase 3 clinical studies have shown the potential therapeutic effect of uppatini in patients with endexual dermatitis.
the product is currently under regulatory review in the United States.
, the application for the new drug in China was accepted by CDE on December 28, 2020.
is a common, chronic, recurrent, inflammatory skin disease, can be manifested as recurrent itching and scratching cycles, resulting in skin pain, cracking.
estimates that 25 percent of adolescents and 10 percent of adults are affected by the disease at some point in their lives.
20%-46% of adult patients with endexual dermatitis suffer from moderate to severe diseases.
it creates a significant physical, psychological and economic burden on individuals affected by disease.
References: China's State Drug Administration Drug Review Center (CDE). Retrieved Jan 22, 2021, From s.2 RINVOQ™ Achieved Superiority Versus DUPIXENT® (dupilumab) For Primary and All Ranked Secondary Endpoints in Phase 3b Head-to-Head in Adults with Atopic Dermatitis, Retrieved December 10, 2020, from the public