Novo Nordisk announced the launch of Esperoct® (antihemophilic factor [recombinant], glycopegylated-exei) for the treatment of adult and pediatric patients with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes, on-demand treatment and control of bleeding episodes, and perioperative management of bleeding.
Esperoct, a glycopegylated form of recombinant antihemophilic factor, temporarily replaces the missing coagulation Factor VIII needed for effective hemostasis in congenital hemophilia A patients. Compared with standard therapies, the Factor VIII in Esperoct is conjugated to a 40-kDa polyethylene glycol molecule which increases the half-life and decreases the clearance, allowing for less frequent dosing.
The approval was based on data from 5 multicenter, open-label trials that included 270 previously treated patients with severe hemophilia A and no history of inhibitors. Data included 80,425 exposure days corresponding to 889 patient-years of treatment. Trial results showed that Esperoct provided effective routine prophylaxis in adults and adolescents dosed every 4 days or in children every 3 to 4 days. Moreover, efficacy was established in the treatment and control of bleeding episodes and perioperative management.
Esperoct was well-tolerated across all studies and age groups. The most common adverse reactions were rash, redness, itching and injection site reactions.
Each vial of Esperoct contains the labeled amount of recombinant Factor VIII in international units (IU). The product is available as a lyophilized powder in dosage strengths of 500, 1000, 1500, 2000, and 3000 per single-dose vial. One IU of Factor VIII activity corresponds to the quantity of Factor VIII in 1 milliliter of normal human plasma.
For more information visit esperoct.com.