By Michael Dabaie
AbbVie Inc. (ABBV) said the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion for Rinvoq for the treatment of adult patients with moderate to severe active rheumatoid arthritis.
The CHMP positive opinion is supported by data from the pivotal Phase 3 SELECT rheumatoid arthritis program evaluating more than 4,400 patients, AbbVie said. The opinion will now be referred to the European Commission for final approval, the company said.
In Phase 3 trials, upadacitinib improved signs and symptoms of rheumatoid arthritis, inhibited radiographic progression and improved physical function, AbbVie said.
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