The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) agreed on a positive opinion for AbbVie’s upadacitinib (RINVOQ), according to the company. The JAK inhibitor is a once-daily selective treatment used for adult patients with moderate to severe active rheumatoid arthritis who are intolerant to 1 or more disease-modifying antirheumatic drugs.

CHMP's positive opinion is a scientific recommendation for marketing authorization to the European Commission, which authorizes marketing approval in the European Union. This opinion is supported by data from a global phase 3 SELECT rheumatoid arthritis program. 4400 patients with moderate to severe active rheumatoid arthritis were evaluated in 5 different trials, including SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE, and SELECT-EARLY.

All primary and secondary endpoints were met, including low disease activity based on Disease Activity Score 28 C-Reactive Protein. Improved response was seen with upadacitinib, both as a monotherapy and in combination with conventional synthetic DMARDs compared to placebo.

The SELECT program showed a consistent safety profile across all five studies, with the most frequent adverse reactions being infections.


REFERENCE

AbbVie receives chmp positive opinion for upadacitinib (rinvoq™) for the treatment of adults with moderate to severe active rheumatoid arthritis [news release]. North Chicago, Ill.; PR Newswire: October 18, 2019. https://www.prnewswire.com/news-releases/abbvie-receives-chmp-positive-opinion-for-upadacitinib-rinvoq-for-the-treatment-of-adults-with-moderate-to-severe-active-rheumatoid-arthritis-300940994.html. Accessed October 18, 2019.