JIVI, haemophilia biological drug, approved by US FDA
On 29 August 2018 US federal agency accepted the clinical use of biopharmaceutical JIVI produced by Bayer HealthCare LLC. Adult and adolescent patients suffering from haemophilia will be treated with the drug to reduce bleeding episodes.
Main new characteristic of JIVI is a more extended period of action, thanks to polyethylene glycol molecule. Half of the molecule dose is still present in the blood after 17,9 hours.
Behind trade name JIVI, the drug is professionally called Antihemophilic Factor (Recombinant), PEGylated.
Bayer designed protein after a product of human gene F8 (coagulation factor VIII). Two alterations to the original protein are the removal of B-domain fragment and conjugation with polyethylene glycol molecule. Its biological synthesis is declared to take place in hamster kidney cells.
Patients with hemophilia A will receive drug in case of:
- sudden bleeding episode,
- bleeding during surgery procedures,
- frequent bleeding episodes.
Numerous clinical and safety trials preceded approval.
More: “Indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for: (1) On-demand treatment and control of bleeding episodes; (2) Perioperative management of bleeding; (3) Routine prophylaxis to reduce the frequency of bleeding episodes”.