On February 6, the CDE website showed that Novartis' ianalumab had applied for marketing approval in China. Ilimumab, acquired by Novartis (from MorphoSys) , is a fully human monoclonal antibody targeting B-lymphocyte activating factor receptor ( BAFF-R ). It possesses a dual mechanism of action: depleting B cells and inhibiting BAFF-R. It can be used to treat various autoimmune diseases, including Sjögren's syndrome, immune thrombocytopenic purpura (ITP), and systemic lupus erythematosus (SLE) . This drug is the first anti- BAFF-R antibody to complete Phase III trials.In the phase III NEPTUNUS-1 study , after 48 weeks of illuminumab treatment, patients with Sjögren's syndrome had a 6.4-point reduction in the EULAR Sjögren's Disease Activity Index (ESSDAI) score, compared to a 5.1-point reduction in the placebo group.
In the phase III NEPTUNUS-2 study, patients with Sjögren's syndrome who received irinumab treatment for 48 weeks experienced a 6.5-point reduction in their ESSDAI score, compared to a 5.5-point reduction in the placebo group.In the Phase III VAYHIT2 study, 54% of patients with primary immune thrombocytopenic purpura (ITP) who received 48 weeks of treatment with illuminumab in combination with eltrombopag had no treatment failure, compared to 30% in the placebo group.

https://bydrug.pharmcube.com/news/detail/8766aef5968878c51cf4aab880ed2629