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NAGLAZYME® (galsulfase) reduced urinary GAG levels

NAGLAZYME reduced urinary glycosaminoglycans

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In the phase 3 clinical trial, urinary GAG excretion was selected as a secondary efficacy variable.

  • The group treated with NAGLAZYME experienced a 75% reduction in mean urinary GAG levels by week 24
  • The tight clustering of urinary GAG values after treatment relative to the wide range of baseline levels demonstrates that the 1 mg/kg of body weight dose provides a sufficient pharmacodynamic response15

* Patients receiving placebo were switched to NAGLAZYME at the beginning of the open-label extension period. Patients in the drug group received NAGLAZYME for a total of 48 weeks; placebo/NAGLAZYME patients received NAGLAZYME during the 24-week open-label extension period only.
† One patient in the placebo/NAGLAZYME group failed to complete the assessment.

 Next: Open-label extension

References

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