In a clinical trial of children aged 5 to 15 years, the impact of VOXZOGO on linear growth was measured over 1 year.
Growth rate before and after 1 year of treatment
At year 4, the rate of growth was 1.88 in/yr.†
*The difference when accounting for group characteristics, including sex and Tanner stage, treatment, baseline age, baseline growth rate, and baseline height Z-score.
†These results are from the long-term follow-up study of the same clinical trial (known as an open-label extension), which did not have a placebo group, and caregivers, patients, and doctors were aware that all children were given VOXZOGO.
‡One child discontinued due to injection pain, and one child discontinued due to fear of needles.
VOXZOGO is approved under accelerated approval based on an improvement in growth rate after 1 year of treatment. Compared to untreated patients in the study, body proportionality did not worsen at 1 year.
Because achondroplasia is a condition that affects multiple aspects of physical development, additional studies on the impact of VOXZOGO over a longer period of time are ongoing, including its effects on final adult height and body proportionality.
*Visit clinicaltrials.gov for the complete list of the trials’ additional study measures (NCT03583697, NCT03989947, NCT03197766, NCT03424018).
Your local BioMarin representative can help you find answers.
What is the most important safety information about VOXZOGO?
What are the most common side effects of VOXZOGO?
How is VOXZOGO taken?
What should you tell the doctor before or during taking VOXZOGO?
You may report side effects to BioMarin at 1-866-906-6100. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see additional safety information in the full Prescribing Information and Patient Information.
What is VOXZOGO used for?