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CompileKe Ke
On April 7, Biogen announced that the European Commission (EC) has approved the subcutaneous injection (SC) agent TYSABRI® (natalizumab, natalizumab) for the treatment of relapsing-remitting multiple sclerosis (MS).
The European Commission’s approval of the route of administration of TYSABRI® SC is based on data from clinical studies DELIVER and REFINE.
Approved by the European Union in 2006, the effectiveness and safety of TYSABRI have been proven through clinical trials and a large amount of real evidence collected in the past 15 years.
TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), a rare opportunistic viral infection associated with death or severe disability.
TYSABRI also increases the risk of encephalitis and meningitis caused by herpes simplex and herpes zoster viruses.
Reference source: The European Commission Grants Marketing Authorization for New Subcutaneous Administration of TYSABRI® (natalizumab) to Treat Relapsing-Remitting Multiple Sclerosis