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On March 17, according to foreign media reports, AbbVie announced that the US FDA has extended the review period for the anti-inflammatory drug RINVOQ Supplemental New Drug Application (sNDA) for the treatment of active psoriatic arthritis (PsA) in adults.
AbbVie recently received information from the FDA requesting an updated assessment of the benefit and risk profile of RINVOQ in the treatment of psoriatic arthritis.
RINVOQ (Upadacitinib) is an oral, once-a-day, selective and reversible JAK inhibitor discovered and developed by AbbVie scientists.
The drug was successful in a large-scale phase III clinical study for the treatment of adult psoriatic arthritis (PsA) last year.
The study is a multi-center, randomized, double-blind, parallel-group, positive drug and placebo-controlled phase III study, in 1705 adult patients with psoriatic arthritis (PsA) who had insufficient response to at least one non-biological DMARD It was carried out in China and evaluated the efficacy and safety of two doses of Rinvoq (15mg and 30mg, once a day) relative to placebo and adalimumab.
The data showed that the study reached the primary endpoint: at week 12, 71% and 79% of patients in the 15mg group and 30mg group achieved ACR20 responses, respectively, and 36% in the placebo group (p<0.
According to the measurement of HAQ-DI score, patients receiving Rinvoq also showed significant improvement in physical function at week 12: the HAQ-DI scores of patients in the 15mg and 30mg Rinvoq treatment groups changed from baseline by -0.
In August 2019, RINVOQ was awarded the world's first batch in the United States for use in adult patients with moderate to severe active rheumatoid arthritis (RA) who are inadequate or intolerant to methotrexate.
The approved dose of RINVOQ for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis is 15 mg.
The industry is very optimistic about Rinvoq's business prospects.
In addition, AbbVie has also received a similar request from the FDA for the use of RINVOQ in the treatment of atopic dermatitis to supplement the new drug application.
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