A subcutaneous formulation of Johnson & Johnson’s bispecific antibody product Rybrevant (amivantamab) is set to be approved in the EU following a nod from the CHMP that has come just weeks after a similar application in the US was hit by a complete response letter. The December letter cited observations made during a standard pre-approval inspection at a manufacturing facility and a refiling is expected this year.
New EU Rybrevant Approval Decisions Turn The Screw On Tagrisso
A manufacturing inspection issue may have put paid to J&J getting a rapid approval for its subcutaneous version of Rybrevant in the US, but a positive opinion from the CHMP plus an expanded EU approval for the IV version are two recent boosts to a franchise taking aim at Tagrisso’s crown.
