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New Indication Alert: Positive CHMP Opinion issued for Third Indication of Roche’s Vabysmo® (Faricimab)

Jun 28, 2024

Roche has announced that the EMA’s CHMP has issued a positive opinion for extension of the marketing authorisation for Roche’s Vabysmo® (faricimab) to include visual impairment due to macular oedema secondary to retinal vein occlusion.  If approved, faricimab will be the first bispecific antibody treatment available in the EU for RVO.  A final decision of the European Commission is expected soon. 

Vabysmo has previously been approved in the US (in October 2023) and Japan (in March 2024) for macular oedema following retinal vein occlusion.  It is approved in 95 countries for nAMD and diabetic macular oedema.