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December 21, 2018

AbbVie seeks US and European authorisations for upadacitinib

AbbVie has submitted applications to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), seeking approvals for the use of its upadacitinib medicine to treat adults with moderate to severe rheumatoid arthritis.

AbbVie has submitted applications to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), seeking approvals for the use of its upadacitinib medicine to treat adults with moderate to severe rheumatoid arthritis.

Upadacitinib is an investigational, oral, small molecule JAK1-selective inhibitor being developed for the treatment of various immune-mediated diseases, including rheumatoid arthritis.

The applications submitted by AbbVie include results from the Phase III SELECT programme designed to assess more than more than 4,000 moderate to severe rheumatoid arthritis patients in five clinical trials.

Intended to evaluate the safety, efficacy and tolerability of the investigational medicine, the studies tracked measures such as ACR responses, Disease Activity Score and radiographic progression inhibition.

Data showed that all the studies met all primary and ranked secondary endpoints, with most frequent serious adverse events being infections.

“If approved, upadacitinib has the potential be a meaningful treatment option for a broad range of rheumatoid arthritis patients.”

AbbVie vice-chairman and president Michael Severino said: “AbbVie is committed to advancing care for the millions of people living with rheumatoid arthritis, many of whom still do not achieve their treatment goals.

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“If approved, upadacitinib has the potential be a meaningful treatment option for a broad range of rheumatoid arthritis patients. We look forward to working with the regulatory authorities throughout the review process.”

In October this year, AbbVie reported data from the SELECT-MONOTHERAPY trial conducted in patients with rheumatoid arthritis who did not have adequate response to methotrexate treatment.

Following 14 weeks of treatment with upadacitinib monotherapy, subjects were found to experience improvements in physical function, health-related quality of life, pain and morning joint stiffness.

The company is also investigating upadacitinib in Phase III trials for psoriatic arthritis, Crohn’s disease, atopic dermatitis, ulcerative colitis and ankylosing spondylitis.

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