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Nexviazyme®
(avalglucosidase alfa)
Designed for Change From the Inside Out

For your patients with Pompe disease

Nexviazyme: An enzyme replacement therapy enhanced with 15 times more M6P moieties than Myozyme1-3

  • Nexviazyme is indicated for long-term enzyme replacement therapy for the treatment of patients one year of age and older with Pompe disease (acid α-glucosidase deficiency).1
  • M6P is critical for the uptake of the rhGAA ERT into muscle cells.1–3*
  • Upon uptake, the GAA enzyme can degrade and help to clear lysosomal glycogen to prevent irreversible muscle damage.1,2
     

Nexviazyme offers patients with LOPD favourable differences in their motor and respiratory function compared to Myozyme1†‡

†6MWT estimated difference: 30.01 m, nominal P=0.04; FVC (% predicted) estimated difference: 2.43%, P=0.06 (not significant).1
 

Safety demonstrated in a phase 3 trial1‡

With Nexviazyme, fewer patients with LOPD experienced IARs and SARs as compared to Myozyme (P-value not assessed).1
 

Simple to start or switch

Each vial of Nexviazyme contains 100mg of medication, compared to 50mg per vial for Myozyme.1,4
 

Resources

Access a range of tools and resources to help support you and your patients’ ongoing treatment with Nexviazyme.

View Resources


*Pre-clinical and animal data may not necessarily predict clinical effect. ‡Phase 3, randomised, double-blind study in patients with LOPD (N=100). Patients were naive to treatment, aged 3 years or older at baseline, and were randomised 1:1 to receive 20 mg/kg of Nexviazyme or Myozyme every 2 weeks for 49 weeks.1,5

Abbreviations

6MWT, 6-minute walk test; ERT, enzyme replacement therapy; FVC, forced vital capacity; GAA, acid α-glucosidase; IAR, infusion-associated reaction; LOPD, late-onset Pompe disease; M6P, mannose-6-phosphate; SAR, serious adverse reaction.

References

  1. Approved Australian NEXVIAZYME Product Information.
  2. Zhu Y et al. Mol Ther 2009;17(6):954–63.
  3. Zhu Y et al. Biochem J 2005;389:619–28.
  4. Approved Australian MYOZYME Product Information. 
  5. Diaz-Manera et al. Lancet Neurol 2021; 20(12): 1012–26.

PBS Information: NEXVIAZYME. This product is not listed on the PBS. This product is funded under the Life Saving Drugs Program.

Please review full Nexviazyme Product Information before prescribing. Full Product Information is available from sanofi-aventis australia pty ltd here or by contacting 1800 818 806.

â–¼ This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.

 

PBS Information: MYOZYME. This product is not listed on the PBS. This product is funded under the Life Saving Drugs Program.

 

Please review full Myozyme Product Information before prescribing. Full Product Information is available from sanofi-aventis australia pty ltd here or by contacting 1800 818 806.

Life Saving Drugs Program - Pompe disease - Guidelines are available at www.health.gov.au/resources/publications/lsdp-pompe-guidelines.

Nexviazyme® and Myozyme​​​​​​​® are registered trademarks of Sanofi.

MAT-AU-2201168-3.0 - 05/2024.