US pharmaceutical major Eli Lilly’s (NYSE: LLY) mirikizumab and China-based Chia Tai Tianqing’s lanifibranor have both entered into the breakthrough therapy review process, marking a significant step in advancing treatments for moderate to severe active Crohn’s disease (CD) and non-cirrhotic non-alcoholic steatohepatitis (NASH) with liver fibrosis, respectively.
Mirikizumab: Anti-IL-23 Monoclonal Antibody for Crohn’s Disease and Other Indications
Mirikizumab, an anti-IL-23 p19 subunit monoclonal antibody (mAb), is under development to treat CD, ulcerative colitis (UC), and plaque psoriasis. It was first approved in Japan for use in UC in March this year. Despite the indication filing being rejected in the US one month later due to manufacturing concerns, it received positive opinions in the European Union with an approval recommendation.
Lanifibranor: PPAR Agonist for NASH and Liver Fibrosis
Lanifibranor is a peroxisome proliferators-activated receptor (PPAR) agonist developed by Inventiva to treat NASH and non-alcoholic fatty liver disease (NAFLD). Chia Tai Tianqing secured a licensing deal with Inventiva in September 2022, granting them exclusive rights to develop, manufacture, and commercialize the drug in Greater China. The drug has previously obtained breakthrough therapy designation (BTD) and fast-track status in the US, highlighting its potential impact on the treatment of NASH.-Fineline Info & Tech
