Eli Lilly Submits New Indication Application for Baricitinib Tablets in China

According to the SmartCom APP, on January 7, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration disclosed that Eli Lilly and Company (LLY.US) submittedBaricitinib TabletsNew indication marketing application has been submitted and accepted. Public information shows that Baricitinib, an oral JAK inhibitor jointly developed by Eli Lilly and Incyte Corporation, has already been approved in China for the indication of rheumatoid arthritis.

It is reported that Baricitinib is an oral JAK inhibitor taken once daily. It has been approved in more than 75 countries and regions for the treatment of patients with rheumatoid arthritis, and in over 50 countries and regions for the treatment of moderate to severe atopic dermatitis. In June 2022, the drug received approval from the U.S. FDA for marketing, intended for the treatment ofAdult Patients with Severe Alopecia Areata. Publicly available information shows that this is also the first systemic therapy approved by the FDA for the treatment of alopecia areata.

In China, Baricitinib was approved for marketing in July 2019, applicable to patients who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs.Moderate to Severe Active Rheumatoid ArthritisAdult patients. In addition, according to the China Drug Clinical Trial Registry and Information Disclosure Platform,Eli Lilly is conducting a Phase 3 clinical trial in China to evaluate the efficacy and safety of baricitinib in adult patients with severe or very severe alopecia areata.

For the indication of alopecia areata, the efficacy and safety of baricitinib have been evaluated in two randomized, double-blind, placebo-controlled Phase 3 clinical trials. Patients participating in these trials had at least 50% hair loss for more than 6 months at baseline. The trial results showed,After 36 weeks of treatment, about one-third of patients receiving a 4 mg dose of baricitinib achieved over 80% scalp hair coverage.. At the same time, about one-third of the patients reachedComplete Regeneration of Eyebrows or LashesOr there is no significant missing indicator.