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Safety Data

Adverse reactions that occurred in ≥5% of patients treated with VOXZOGO and at a rate greater than placebo in Study 11,*

*Includes adverse reactions occurring more frequently in the VOXZOGO arm and with a risk difference of ≥5% (ie, difference of >2 subjects) between treatment arms.
†Injection site reactions occurring more frequently in VOXZOGO-treated subjects than placebo.
‡Includes the preferred terms: gastroenteritis and gastroenteritis, viral.
§Includes the preferred terms: dizziness, presyncope, procedural dizziness, and vertigo.
||Includes the preferred terms: fatigue, lethargy, and malaise.

8 of 60 (13%) patients on VOXZOGO® experienced a transient decrease in blood pressure compared with 3 of 61 (5%) on placebo1

Decreases in blood pressure were identified during periods of frequent vital sign monitoring.

  • Median onset: 31 minutes (range, 18-120 minutes)
  • Median resolution: 31 minutes (range, 5-90 minutes)
  • 2 (3%) patients treated with VOXZOGO® each had one symptomatic episode of blood pressure with vomiting and/or dizziness compared with 0 patients on placebo
  • Patients with significant cardiac or vascular disease and patients on antihypertensive medicinal products were excluded from participation in VOXZOGO® clinical trials

97% of children on VOXZOGO® (58/60) remained on treatment during the 1-year clinical trial1,*

*One patient discontinued after 2 days due to pain from injections and one after 6 days due to fear of needles.2

References:

  1. VOXZOGO® [package insert]. Novato, CA: BioMarin Pharmaceutical Inc; 2021.
  2. Savarirayan R, Tofts L, Irving M, et al. Once-daily, subcutaneous vosoritide therapy in children with achondroplasia: a randomised, double-blind, phase 3, placebo-controlled, multicentre trial. Lancet. 2020;396:684-692.