Danish pharmaceutical firm Novo Nordisk has received biologics licence application (BLA) approval from the US Food and Drug Administration (FDA) for its recombinant coagulation factor VIII, Novoeight.
Novoeight is intended for adults and children with haemophilia A to control and prevent bleeding, perioperative management as well as routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
The drug has been studied in the guardian clinical program, one of the comprehensive pre-registration clinical trial programmes in the field of haemophilia therapy, in over 210 severe haemophilia A patients.
According to the company the completed trials of Novoeight showed good efficacy in preventing and treating bleeds and had no confirmed inhibitor development, while all patients in the surgery trial were treated effectively with the drug.
Novoeight is scheduled to be launched with the newly introduced prefilled device 'MixPro' after April 2015 in the US.
Novo Nordisk executive vice president and chief science officer Mads Krogsgaard Thomsen said, "The approval of Novoeight marks an important step in offering a new alternative for people with haemophilia A, and demonstrates our commitment to haemophilia."
In September 2013, the company had also received positive opinion for the drug from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).
Haemophilia is a chronic, inherited bleeding disorder that primarily affects males. People with haemophilia A are either missing or have a malfunctioning factor VIII protein, which is necessary for proper blood clotting.
