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Nexviazyme®
(avalglucosidase alfa)
Long-Term Durability

Maintenance of treatment effect for up to 6.5 years in an open-label study1,2

Nexviazyme showed long-term durability of treatment effect for up to 6.5 years in an open-label uncontrolled study1

*In the open-label, uncontrolled NEO1/NEO-EXT study in patients with LOPD.1

Patients with LOPD completing the NEO1 trial were eligible to continue into the open-label uncontrolled NEO-EXT trial. Patients were treatment naive or switched from Myozyme (alglucosidase alfa) and received NEXVIAZYME (5, 10, or 20 mg/kg every other week [qow]) for 6 months in NEO1 before entering NEO-EXT and continued their NEO1 dose until all proceeded with 20 mg/kg qow. Safety and efficacy, a pre-specified exploratory secondary outcome, were assessed.2

Respiratory and functional muscle strength remained stable for up to 6.5 years in most patients. The slope estimates for upright forced vital capacity (FVC) %predicted (95% confidence intervals) were -0.473/year (-1.188, 0.242) and -0.648/year (-1.061, -0.236) in the Naïve and Switch Groups, respectively. Six-minute walk test (6MWT) %predicted was also stable for most participants, with slope estimates of -0.701/year (-1.571, 0.169) and -0.846/year (-1.567, -0.125) for the Naïve and Switch Groups, respectively. Most patients aged <45 years at NEO1 enrolment had Improvement in 6MWT distance, in both the Naïve and Switch Groups.2

Nexviazyme was generally well-tolerated for up to 6.5 years in NEO-EXT with a safety profile consistent with that in NEO1. No deaths or treatment-related life-threatening serious adverse events occurred.2

Access Nexviazyme Clinical Trials

6MWT, six minute walking test; FVC, forced vital capacity; LOPD, late-onset Pompe disease; qow, every other week.

  1. Nexviazyme Australian Approved Product Information.
  2. Dimachkie MM et al. Long-term safety and efficacy of avalglucosidase alfa in patients with late-onset Pompe disease. Neurology. 2022 Aug 1;99(5):e536-e548. doi: 10.1212/WNL.0000000000200746.

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-2201163 - 2.0 - 05/2024