Regeneron Update November 2020
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.