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.

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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.

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