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.
Comparable mean change in estimated glomerular filtration rate (eGFR) observed vs agalsidase beta over 2 years1,3View the BALANCE clinical data
Safety profile was assessed through long-term clinical trials including a head-to-head trial with an agalsidase beta control group1,4,5See the BALANCE safety profile
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)1,4Review the BALANCE data
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)1,5Review the NAÏVE data
In the Elfabrio Prescribing Information, BALANCE is referred to as Trial 2 and NAÏVE as Trial 1.