He has a wealth of experience of Regulatory Affairs in the US, EU, Japanese and international markets, and was, among other projects, responsible for overseeing the lifecycle development for new indications for the orphan drug NovoSeven
, a recombinant human coagulation Factor VIIa (rFVIIa), intended for promoting haemostasis by activating the extrinsic pathway of the coagulation cascade.
The use of recombinant factor Vila (NovoSeven
) in a patient with a factor XI deficiency and a circulating anticoagulant.
Recombinant factor VIIa (NovoSeven
) as a hemostatic agent after surgery for congenital heart disease.
We discussed with a hematologist whether to use eptacog alpha (Novoseven
[R]), but the hematologist did not recommend to use such drug because of the patient's age and expected prognosis.
Recombinant activated factor VII (rFVIIa, NovoSeven
) is a systemic prothrombotic agent approved for use in the setting of hemophilia A or B and inhibitors to factor VIII or factor IX,5 but now has been increasingly used in the management of off-label indications involving uncontrolled hemorrhage and various surgical scenarios, including excessive intraoperative and postoperative bleeding.
(178.) According to the package insert, Factor VII, brand-name NovoSeven
, is produced by cloning the gene for human Factor VII, expressing it in baby hamster kidney cells, secreting it into a culture media containing newborn calf serum in its single-chain form, and then proteolytically converting it by auto- catalysis to the active two-chain form during a chromatographic purification process.
Acquired isolated factor VII deficiency associated with severe bleeding and successful treatment with recombinant FVIIa (NovoSeven
(17.) Shander A, Goodnough LT, Rakto et al: Consensus recommendations for off lable use of Recombinant factor VIIA (Novoseven
) therapy, P&T 2005; 30: 644-58.
, a Factor VIIa product sold by Novo Nordisk of Denmark, posted worldwide sales of 8.9 billion kroners in 2012, or about $1.6 billion in current dollars.