Biogen Inc.
EMPAVELI
C3 glomerulopathy (C3G) or primary IC-MPGN
Date
TBD
Approval decision · Date TBD estimated
What's at stake
A final FDA approval decision on EMPAVELI for C3 glomerulopathy (C3G) or primary IC-MPGN is expected Date TBD.
Primary source
· SEC 8-K
verified 14h ago
“EMPAVELI is the only FDA-approved treatment for pediatric patients (12+ years) with C3G and the only FDA-approved treatment for patients with post-transplant C3G disease recurrence.”