Posted by Michael Wonder on 20 Dec 2018
AbbVie submits new drug application to U.S. FDA and marketing authorisation application to EMA for upadacitinib for treatment of adults with moderate to severe rheumatoid arthritis
20 December 2018 - Regulatory applications supported by robust SELECT Phase 3 program evaluating more than 4,000 patients with moderate to severe rheumatoid arthritis.
AbbVie announced that it has submitted a New Drug Application (NDA) to the U.S. FDA and a marketing authorization application (MAA) to the 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 3 rheumatoid arthritis program evaluating more than 4,000 patients with moderate to severe rheumatoid arthritis across five Phase 3 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.
