Picture what
long-lasting
treatment can do1,2*
Elfabrio is an enzyme replacement
therapy (ERT) approved for the treatment
of adults with confirmed Fabry disease.1
For your ERT-experienced and treatment-naïve patients:
The PEGylated ERT for Fabry1,2
| * | Elfabrio has an initial half-life of 78.9 ± 10.3 hours. Clinical studies have not established that pharmacological characteristics, including half-life, result in superior efficacy or safety based on clinically relevant endpoints. Infusions are every 2 weeks.1 |
PEG, polyethylene glycol.
Efficacy
Comparable mean change in estimated glomerular filtration rate (eGFR) observed vs agalsidase beta over 2 years1,3
View the BALANCE clinical data
Tolerability
Safety profile was assessed through long-term clinical trials including a head-to-head trial with an agalsidase beta control group1,4,5
See the BALANCE safety profile
Immunogenicity
Low rates of anti-drug antibody (ADA) formation with Elfabrio for naïve and treatment-experienced patients1,3†‡
See the BALANCE ADA data| † | The effect of IgG ADAs on the effectiveness of Elfabrio has not been fully characterized. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. |
| ‡ | In Trial 1 (NAÏVE), 4 out of 14 (28.5%) treatment-naïve patients had treatment-emergent ADAs. In Trial 2 (BALANCE), 6 out of 52 (11.5%) treatment-experienced patients had treatment-emergent ADAs.1,3 |
IgG, immunoglobulin G.
Which patients would you consider for Elfabrio?
Patients switching from agalsidase beta
Studied head-to-head in switch patients against agalsidase beta in a 2-year, double-blind, active-controlled trial (BALANCE)1,4
Review the BALANCE data
Treatment-naïve patients
Studied in treatment-naïve patients (including those who had not received ERT for >26 weeks) in a phase 1/2 trial with a 60-month, long-term extension (NAÏVE)1,5
Review the NAÏVE dataIn the Elfabrio Prescribing Information, BALANCE is referred to as Trial 2 and NAÏVE as Trial 1.
Looking to learn more about Fabry disease and how it may affect your patients?
