Tags : Esperoct

Novo Nordisk’s Esperoct (turoctocog alfa pegol, N8-GP) Receives European Commission

Shots: The approval is based on results from pre-registration clinical programme assessing Esperoct in 270 patients with severe hemophilia A with 5+years of clinical exposure. The authorization covers all 28 European Union member states The marketing authorization follows EMA’s CHMP positive opinion granted on Apr 26, 2019 with its expected launch in European countries in […]Read More

Novo Nordisk’s Esperoct (turoctocog alfa pegol, N8-GP) Receives CHMP’s Positive

Shots: The positive opinion is based on largest pre-registration clinical programme assessing Esperoct (FD, IV, q4days) in 270 patients previously treated with severe hemophilia A and more than 5 years of clinical exposure   The study resulted in effective routine prophylaxis in people with severe hemophilia A, efficacious in treatment and control of bleeding episodes […]Read More

Novo Nordisk Receives BLA Approval for Esperoct (turoctocog alfa pegol,

Shots: The BLA approval is based on the trial assessing Esperoct (turoctocog alfa pegol, N8-GP) in 270 patients with previously treated people (PTPs) with severe haemophilia A The study resulted in maintanince of low median ABR of 1.18, efficacious in treatment & control of bleeding episodes, perioperative management and was well tolerated with no safety […]Read More