EMA Recommends Upadacitinib for Rheumatoid Arthritis

Troy Brown, RN

October 18, 2019

The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) recommended marketing authorization for upadacitinib (Rinvoq, AbbVie Deutschland GmbH & Co KG) for the treatment of patients with rheumatoid arthritis, according to an EMA opinion summary.

The complete indication is moderate-to-severe active rheumatoid arthritis in adults with inadequate response to, or intolerance to, at least one of multiple disease-modifying antirheumatic drugs. It may be given as monotherapy or together with methotrexate.

Upadacitinib is an immunosuppressant and a selective, reversible janus kinase (JAK) inhibitor that reduces rheumatoid arthritis symptoms by preferentially inhibiting "signalling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2," the EMA explains in the summary.

The US Food and Drug Administration approved upadacitinib for the same indication on August 19, 2019.

Upadacitinib is taken once daily and will be sold as 15-mg prolonged-release tablets.

The most frequently seen adverse effects for upadacitinib are upper respiratory tract infections, nausea, increased blood creatine phosphokinase, and cough. The most frequent serious adverse effects are severe infections.

The committee emphasizes that upadacitinib should be prescribed by physicians with experience diagnosing and treating rheumatoid arthritis.

The summary of product characteristics will include detailed recommendations for use of the product and will be published in the European public assessment report, which will be made available in all official European Union languages after the European Commission grants marketing authorization.

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