Regeneron Update November 2020

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Regeneron Provides Update on the Garetosmab Phase 2 LUMINA-1 Trial in Fibrodysplasia Ossificans Progressiva (FOP)

Regeneron today notified clinical investigators to pause dosing of the investigational therapy garetosmab (REGN2477) in the ongoing Phase 2 LUMINA-1 trial in patients with the ultra-rare genetic disorder fibrodysplasia ossificans progressiva (FOP). The decision was based on reports of fatal serious adverse  events in the trial during the open-label portion, during which all patients received active treatment. These deaths are being further investigated to understand if they are related to garetosmab treatment.

During the 28-week double-blind treatment period, there were no deaths in the trial.

To read the full statement, click here.