![Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei]](/content/dam/novonordisk/esperoctpro/global/esperoct-logo.png){kind=logo}
In a phase 1 study with adult patients, Esperoct® achieved a 60% longer half-life compared to SHL FVIII products.1,a
EXTEND HALF-LIFE BEYOND THE STANDARD
EXTEND HALF-LIFE BEYOND THE STANDARD
In open-label clinical trials, Esperoct® achieved a longer half-life across age groups when compared to standard half-life (SHL) Factor VIII products.1,a
LONGER HALF-LIFE COMPARED TO SHL FVIII PRODUCTS
In patients ≥18 years of age
aA phase 1, open-label study evaluated the safety and pharmacokinetic properties of Esperoct® in 26 PTPs. Patients received a single dose of 25, 50, or 75 IU/kg of their previous SHL product (pdFVIII or rFVIII), followed by the same dose of Esperoct®. To allow for comparison, all results were adjusted to a 50 IU/kg dose of each product.1
ESPEROCT® ACHIEVED AN UNPRECEDENTED HALF-LIFE
Compared to other extended half-life (EHL) products, Esperoct® achieved an unprecedented 22-hour half-life in adults.2,b,c
bIn a phase 3, open-label study, safety, efficacy, and pharmacokinetics (PK) of Esperoct® were evaluated in previously treated patients (PTPs) aged ≥12 years with severe hemophilia A. Single-dose PK studies were performed in 42 adults after receiving Esperoct® 50 IU/kg.2,3
cMean half-life in adults and adolescents, compared with other EHL FVIII products; the mean half-life in adults is 19.7 hours for Eloctate®, 14.7 for Adynovate®, and 17.9-18.6 for Jivi®.4-6
In patients <12 years of age
In an open-label study with pediatric previously treated patients, Esperoct® achieved an 85% longer half-life compared to SHL FVIII products.7,d
dIn a phase 3 study of children (aged <12 years) a single-dose PK comparison was performed in 27 children between previous SHL products and Esperoct® at the same administered dose prior to the start of routine prophylaxis. Half-life comparison is based upon the estimated half-life derived from a population based model. During the main phase, 68 children received prophylaxis at an average dose of approximately 65 IU/kg twice weekly for 26 weeks.7
KEEP THEM COVERED LONGER
In a phase 3 study of children (aged <12 years), Esperoct® achieved a 14.3-hour mean half-life.1,8,d,e
eGeometric mean terminal half-life in 23 children. The subjects were 12 children aged 0-5 years and 10 children aged 6-11 years. Estimated geometric terminal mean half-life was 14.7 hours in the younger cohort and 13.8 hours in the older cohort.7,8
Esperoct® extends half-life through PEGylation.2
Trial prescription program.
Qualifying patients can receive a trial prescription for Esperoct®.
To learn more about our trial prescription program, please call 1-844-668-6732 to speak with a NovoSecure™ Specialist.
