U.S. pharmaceutical giant Eli Lilly announced it has received a second marketing approval from the National Medical Products Administration (NMPA) for Taltz (ixekizumab). The IL-17A monoclonal antibody (mAb) is now approved to treat active ankylosing spondylitis (AS) in patients with a poor response to conventional therapy.
Drug Background
Taltz was first approved in China in August 2019 for moderate-to-severe plaque psoriasis suitable for systemic therapy or phototherapy. The drug was included in the National Reimbursement Drug List (NRDL) in December 2021.
Study Results
The approval for AS is based on a randomized, double-blind, placebo-controlled Phase III RHCH study in China. After 16 weeks of treatment, a significantly higher proportion of radiologically positive axial spondyloarthritis (r-axSpA) patients in the ixekizumab group achieved ASAS40 compared to the placebo group, meeting the primary endpoint.-Fineline Info & Tech
