CHMP recommends approval of Rinvoq for severe active rheumatoid arthritis.- AbbVie

AbbVie announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Rinvoq (upadacitinib), a once-daily selective and reversible JAK inhibitor, for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). The positive opinion is for use of upadacitinib as monotherapy or in combination with methotrexate.

The CHMP positive opinion is supported by data from the global Phase III SELECT rheumatoid arthritis program, evaluating more than 4,400 patients with moderate to severe active rheumatoid arthritis in five pivotal studies. Across all five trials � SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE and SELECT-EARLY � all primary and ranked secondary endpoints were met, including low disease activity based on Disease Activity Score 28 C-Reactive Protein (DAS28-CRP)<=3.2, clinical remission based on das28-crp><2.6 and acr20 50 depending on study design improved response was seen with upadacitinib both as monotherapy and in combination with conventional synthetic dmards compared to placebo methotrexate or adalimumab depending on study design. data from the select program showed a consistent safety profile across the five studies. the most frequently reported adverse reactions were infections.>