By Colin Kellaher
The U.S. Food and Drug Administration on Friday said it approved BioMarin Pharmaceutical Inc.'s Voxzogo injection to treat children with the most common form of dwarfism.
The agency said the approval covers Voxzogo to improve growth in children five years of age and older with achondroplasia and open epiphyses, meaning those patients still have the potential to grow.
The FDA said Voxzogo is the first drug approved in the U.S. to treat achondroplasia, a genetic condition that causes severely short stature and disproportionate growth.
The FDA said it gave the green light to Voxzogo under its accelerated approval pathway, which allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need. The agency said it is requiring a post-marketing study assessing final adult height as a condition of the accelerated approval.
BioMarin, a San Rafael, Calif., biotechnology company, in August said the European Commission approved Voxzogo for the treatment of children from the age of two until growth plates are closed, which occurs after puberty when children reach final adult height.
Shares of BioMarin were recently up 5.4% to $87.37.
Write to Colin Kellaher at firstname.lastname@example.org
(END) Dow Jones Newswires