Upadacitinib is filed at EMA and at FDA to treat moderate to severe rheumatoid arthritis.- AbbVie

AbbVie announced that it has submitted a New Drug Application (NDA) to the FDA and a marketing authorization application (MAA) to the European Medicines Agency (EMA) for upadacitinib, an oral investigational JAK1-selective inhibitor, for the treatment of adult patients with moderate to severe rheumatoid arthritis. The NDA and MAA are supported by data from the global upadacitinib SELECT Phase III rheumatoid arthritis program evaluating more than 4,000 patients with moderate to severe rheumatoid arthritis across five Phase III studies.

In all studies, upadacitinib met all primary and ranked secondary endpoints. The most frequent serious adverse events were infections. Top-line results from these clinical studies were previously announced. Upadacitinib is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

About the SELECT Study Program- The robust SELECT Phase III rheumatoid arthritis program evaluates more than 4,900 patients with moderate to severe rheumatoid arthritis in six studies. The studies include assessments of efficacy, safety and tolerability across a broad range of rheumatoid arthritis patients. Key measures of efficacy evaluated include ACR responses, Disease Activity Score (DAS28-CRP) and inhibition of radiographic progression. More information on these trials can be found at www.clinicaltrials.gov (NCT02706847, NCT03086343, NCT02629159, NCT02706873, NCT02706951, NCT02675426).