Shots:The US FDA has accepted the BLA for Mim8 (denecimig; pre-filled, single-use pen) as routine prophylaxis to prevent or reduce bleeding episodes in adult & pediatric pts with hemophilia A (congenital FVIII deficiency), with or without inhibitorsBLA was supported by FRONTIER2 trial assessing Mim8 (QW/QM) in pts (≥12yrs), FRONTIER3 trial assessing it in…
Shots:The P-III (FRONTIER3) trial assessed Mim8 (SC) in 70 pts (1-11yrs.) with hemophilia A ± FVIII inhibitors in 2 parts: P1 involves Q1W prophylaxis therapy until 26wks. after which pts can stay on Q1W or switch to QM for further 26wks.; regulatory filings expected in 2025P1 data showed 0.53 mean & 0 median…

