Novo Nordisk has received U.S. FDA approval for Esperoct (turoctocog alfa peg, N8-GP) for the treatment of children and adults with haemophilia A.
Today’s decision permits physicians to prescribe the drug for routine prophylaxis to reduce the number of bleeding episodes, on-demand treatment and control of bleeding episodes, and perioperative management of bleeding.
The approval comes on the back of data from a clinical programme involving 270 treated people with severe haemophilia A, including those with 5 years of clinical exposure.
Experoct clearly demonstrated provision of effective routine prophylaxis through a simple fixed dosing regimen of one injection every four days for adults or twice-weekly for children.
“We are excited about the approval of ESPEROCT in the US, and we consider it an important expansion of the treatment options Novo Nordisk can offer people with haemophilia A.” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
“We are confident that ESPEROCT will provide people with haemophilia A a less burdensome and simple, fixed dosing regimen for prophylaxis and treatment of bleeding episodes, resulting in improved quality of life.”
However due to third-party intellectual property agreements, Novo Nordisk will be unable to launch Esperoct before 2020 in the U.S.A.