Eli Lilly's Baricitinib Receives NMPA Approval for New Indication in China

On April 16, according to the NMPA official website,Eli Lilly(LLY.US) Baricitinib Tablets Receive New Indication Approval in China (Application No.: JXHS2300005).Baricitinib, an oral JAK inhibitor jointly developed by Eli Lilly and Incyte, was approved in the United States for the treatment of rheumatoid arthritis in 2018. It later expanded its indications to include coronavirus infection and alopecia areata. In June 2022, it was approved for the treatment of adult patients with severe alopecia areata, making it the first FDA-approved oral therapy for alopecia areata. This also supports the continued growth of Baricitinib in the U.S. market.

In China, Baricitinib was approved for marketing in July 2019 for the treatment of adult patients with moderately to severely active rheumatoid arthritis. In March last year, it was approved for a new indication of alopecia areata. According to the Insight database, Baricitinib has initiated 9 Phase III clinical trials in China. In addition to the approved indications, these include systemic lupus erythematosus, juvenile idiopathic arthritis, and more.

Previously, Eli Lilly and Company announced the results of the Phase III JUVE-BASIS study on baricitinib for the treatment of juvenile idiopathic arthritis (JIA), which showed that baricitinib demonstrated good efficacy and safety in refractory JIA patients.

Editor: Guo Mingyu