AbbVie Korea said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Rinvoq (Ingredient: upadacitinib), a once-daily selective and reversible Janus kinase (JAK) inhibitor treating rheumatoid arthritis.

The CHMP gave a positive opinion for using upadacitinib as monotherapy or in combination with methotrexate in treating 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 company said.

It received the CHMP positive opinion based on the data from its global phase 3 SELECT rheumatoid arthritis program, evaluating more than 4,400 patients with moderate to severe active rheumatoid arthritis in five pivotal studies.

The CHMP positive opinion is a scientific recommendation for marketing authorization by the European Commission, which gives marketing approval in the EU region. The marketing authorization is valid in all member states of the EU, as well as Iceland, Liechtenstein, and Norway. The Commission’s decision comes out within 67 days following the CHMP opinion.

The company said it met all primary and secondary endpoints across all five trials – SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE, and SELECT-EARLY -- 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.

Also, it saw improved response 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, and the most frequently reported adverse reactions were infections.

"Rheumatoid arthritis is a chronic and debilitating disease affecting an estimated 23.7 million people worldwide," AbbVie Vice Chairman Michael Severino said. "While significant treatment advances have been made over the past 20 years, many people living with the disease still do not achieve remission, and the need for novel, innovative treatment options is critical.

The company is pleased with this positive opinion from the CHMP recognizing upadacitinib's potential for patients with moderate to severe active rheumatoid arthritis, Severino said.