CHMP backs Gazyvaro extension as AstraZeneca withdraws EU antibody application

The EMA’s human medicines committee recommended extending Gazyvaro’s use to systemic lupus erythematosus at its November 2026 meeting, while AstraZeneca withdrew its European marketing application for a monoclonal antibody intended for a subset of amyloidosis patients, according to EMA and Endpoints News.

Endpoints reported that the antibody had previously failed two late-stage studies in a broader patient population. The report snippet does not name the candidate or give further details about the withdrawal. EMA said the committee issued seven positive opinions on new medicines and 11 positive opinions on extensions of therapeutic indications at the meeting. The Gazyvaro recommendation was an extension of use, rather than a recommendation for a new medicine.