BeiGene and EUSA Receive NMPA’s Approval of Sylvant (siltuximab) in China for Idiopathic Multicentric Castleman Disease
Shots:
- The approval is based on the P-II trial to evaluate siltuximab vs PBO in 79 patients with iMCD across 19 countries including 16 patients from China
- The 1EPs of the study were durable tumor & symptomatic response with a significant difference in both responses (34% vs 0%) & complete resolution or stabilization of iMCD symptoms @18wks. without treatment failure. A subgroup analysis showed no difference in demographic & baseline disease characteristics b/w Asian & overall patient population, efficacy & safety data were consistent with an overall population
- Siltuximab is a mAb that neutralizes IL-6 in multiple inflammatory conditions & is approved in the US, EU & other countries globally
Ref: Businesswire | Image: BeiGene
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