Last Updated on October 14, 2024 by The Health Master
San Rafael: BioMarin Pharmaceutical Inc. has recently announced that the U.S. Food and Drug Administration (USFDA) has granted accelerated approval to VOXZOGO (vosoritide) for Injection, indicated to increase linear growth in pediatric patients with achondroplasia five years of age or older with open epiphyses (growth plates).
This indication is approved under accelerated approval based on an improvement in annualized growth velocity (AGV).
Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory studies.
To fulfill this post-marketing requirement, BioMarin intends to use the ongoing open-label extension studies compared to available natural history.
“Voxzogo is a medical first that is rooted in BioMarin’s focus on molecular genetics and targets the underlying cause of the condition.
More than a decade of scientific research underpins the medical advance that Voxzogo represents.
“We thank the USFDA for recognizing its value as the first therapeutic treatment option for children with achondroplasia,” said Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin.
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