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MPA approval in China of Sylvant for Idiopathic Multicentric Castleman Disease. BeiGene + EUSA Pharma

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Last updated:20th Dec 2021
Published:5th Dec 2021
BeiGene, Ltd. and EUSA Pharma (UK), Ltd. announced that the China National Medical Products Administration (NMPA) has approved Sylvant (siltuximab for injection) for the treatment of adult patients with multicentric Castleman disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpes virus-8 (HHV-8) negative, also known as idiopathic MCD (iMCD).

This disease is a rare, life-threatening, and debilitating condition of the lymph nodes and related tissues.

Siltuximab is a monoclonal antibody approved in the United States, European Union, and other countries and regions around the world.

The approval of siltuximab for the treatment of iMCD was supported by clinical results from a multinational, randomized, double blind, placebo-controlled Phase II trial (NCT01024036) conducted in 79 patients from 19 countries and regions, including 16 patients from China.

Condition: Castleman disease
Type: drug

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