Role of Roche’s HEMLIBRA in the Hemophilia A Treatment
Hemophilia A Treatment Landscape
Despite historical ups and downs, hemophilia A patient treatment has significantly improved over the past 40 years. The modern advancement of hemophilia therapies began with the revolutionary discovery of cryoprecipitate in 1964. Several years later, scientists discovered that plasma-derived factors are focused on FVIII products. This category saw the approval of a number of hemophilia A drugs that were easier to administer than cryoprecipitate or fresh-frozen plasma, such as FEIBA (Pfizer), MONOCLATEP (CSL Behring), and HEMOFIL-M. The development of recombinant therapy in the 1980s changed the situation for those who have hemophilia A.
There were only short half-life (SHL) recombinant medicines available prior to the approval of the first extended half-life (EHL) in the US (ELOCTATE; 2014). Other treatments avoid using the inhibitor-specific drugs utilized in hemophilia A. One of the most profitable bypass agents is Novonordisk's NOVOSEVEN, which holds the majority of the hemophilia A market share in comparison to Takeda's FEIBA and OBIZUR (not yet approved in Japan). Due to the adoption and use of EHL treatments, which reduced the frequency of injection to a deplorable level, the market for plasma-derived FVIII has already fallen and sales of SHL products have started to decline.
HEMLIBRA: Target patient population and strong uptake
The hemophilia A market products have remained quite fragmented because no one therapy has been able to capture a sizable portion of the market; however, the release of HEMLIBRA in 2017 changed this situation. With or without factor VIII inhibitors, HEMLIBRA, a bispecific factor IXa and factor X-directed antibody, is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency), who are aged newborn and older. For hemophilia A patients taking inhibitors, HEMLIBRA was first approved in the US (November 2017), then in Europe (February 2018), and finally in Japan (March 2018).
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