Biogen's subcutaneous injection of natalizumab is approved in the EU for the treatment of multiple sclerosis

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