FDA approves first hemophilia A drug to extend interval between prophylactic infusions in adults and children

June 10, 2014

FDA has approved Antihemophilic Factor (Recombinant), Fc Fusion Protein (Eloctate, Biogen Idec) for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with hemophilia A.

FDA has approved Antihemophilic Factor (Recombinant), Fc Fusion Protein (Eloctate, Biogen Idec) for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with hemophilia A.

Eloctate is the first recombinant hemophilia A therapy with prolonged circulation in the body. It is the only treatment for hemophilia A to reduce the frequency of bleeding episodes with prophylactic infusions every 3 to 5 days, offering people with hemophilia A the potential to extend the interval between prophylactic infusions.

“We believe Eloctate provides a meaningful advance for people with hemophilia A as it offers the potential to extend the interval between prophylactic [protective] infusions,” according to Andrew Law, Biogen Idec spokesperson.

Studies show people with severe hemophilia who follow a prophylactic infusion schedule experience fewer bleeding episodes and associated risks, according to Law.

“Based on conversations with healthcare providers and the hemophilia community, infusion frequency is one of the largest challenges for people with hemophilia,” he said.

According to the National Hemophilia Foundation (NHF) guidelines, traditional prophylactic hemophilia A therapy involves infusions 3 times per week or every other day, which equates to approximately 150 to 180 infusions per year.

The recommended starting prophylactic regimen for Eloctate is 50 IU/kg every 4 days. Based on clinical response, the regimen may be adjusted in the range of 25 to 65 IU/kg and every 3 to 5 days.

Eloctate's approval is based on results from the global, phase 3 A-LONG clinical study, as well as interim pharmacokinetic, or PK, and safety data from the phase 3 Kids A-LONG study. PK is the measurement of the presence of the therapy in a person’s body over time. Common adverse reactions (incidence of greater than or equal to 1%) reported in the A-LONG study were arthralgia (joint pain) and malaise (general discomfort).