The Front Room — a clinical regulatory commons
RSS
← Back to The Docket
SEP 29 2026
UPCOMING · 118 DAYS TO PDUFA

Novo Nordisk denecimig $NVO

for hemophilia A (with or without inhibitors) — prophylaxis

BLA · Standard Review

Accepted NOV 29 2025.

About

Hemophilia A is a genetic disorder that impairs blood clotting due to a deficiency in factor VIII, leading to frequent and severe bleeding episodes. Denecimig is a bispecific antibody designed to mimic the function of factor VIII, helping the blood clot more effectively. By acting as a substitute for the missing protein, it may reduce the risk of bleeding and improve quality of life for those with hemophilia A.