New drug for type A haemophilia! Bayer's long-acting drug Jivi (BAY94-9027) has been approved by three major markets in the United States, Japan and Europe

Bayer, the German pharmaceutical giant, recently announced that the European Commission (EC) has approved Jivi (BAY94-9027) for the treatment and prevention of bleeding in patients with haemophilia A among adolescents and adults aged 12 and over who have been treated in the past. Jivi recommends preventive treatment every 5 days, or adjusted to 7 days or 2 times a week, depending on the patient's clinical characteristics.
Jivi is a long-acting, point-specific polyglycol recombinant human coagulation factor VIII (PEG-rFVIII) that delivers higher sustained levels of FVIII and has an extended blood half-life due to polyglycolization at specific bits. In the United States and Japan, Jivi was approved in late August and mid-September, respectively. The EU approval also marks Jivi's third major regulatory approval, the third type A haemophilia drug in Bayer's haemophilia portfolio, and the other two are Kovaltry and Kogenate-FS.
the Chinese market, Kovaltry was approved at the end of July this year for routine preventive treatment, on-demand treatment, and management of peri-surgical bleeding events in children and adults with type A blood disorders. Kovaltry is an unmodified, full-length recombinant coagulation factor VIII product that is used preventively twice or three times a week in clinical trials to effectively control and prevent bleeding events in patients with type A blood.
jivi's approval is based on positive data from Phase III study PROTECT VIII. The study assessed the efficacy and safety of Jivi for preventive treatment, on-demand treatment, and peri-surgical management. The results showed that Jivi had a good anti-bleeding effect when taking preventive medication once every 7 days, 1 time every 5 days and 2 times a week. In addition, Jivi can effectively control bleeding events during surgery and effectively treat all bleeding events, in most cases only once or twice intravenously.
currently, the standard treatment for haemophilia type A is the clotting factor VIII replacement therapy, which requires regular infusion and maintaining sufficient VIII levels high enough to prevent bleeding. Given the short half-life of VIII products currently on the market, preventive medications may require frequent dosing, usually every other day or three times a week.
Jivi achieves the purpose of extending half-life by carefully inserting a cysteine residue (Cys) into the surface of the recombinant human coagulation factor VIII protein as an attachment point to a polyg glycol (PEG) polymer, while retaining the biological activity of rFVIII.
type A haemophilia is also known as clotting factor VIII defect or classic haemophilia, which is a recessive hereditary hemorrhagic disease caused by x chromosomal chain clotting factor VIII or molecular structure abnormalities, most commonly in men. Type A haemophilia is usually caused by a lack of VIII factors in the body, characterized by the patient's blood can not coagulate normally, resulting in uncontrolled and frequent persistent or spontaneous bleeding, especially bleeding into the joints, muscles or other tissues, resulting in chronic joint damage. External injuries, even minor ones, can have serious consequences. Compared with normal people, patients with type A haemophilia have significantly longer clotting time. It is estimated that the incidence of haemophilia A is about one in 5,000, about 30,000 in Europe, about 14,000 in the United States and about 5,000 in Japan.
in the past few decades, clinical treatment of haemophilia has come a long way, with life expectancy increasing from 11.4 years in 1920 to normal life expectancy. At present, the research goal in the field of haemophilia is mainly to reduce the burden of treatment and provide patients with quality of life. (Bio Valley)