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The drug, Sohonos, was approved in adults and pediatric patients, suffering from fibrodysplasia ossificans progressiva (FOP), which results in a progressive loss of mobility and reduced life expectancy.
The regulator approved use of the drug in girls aged 8 years and above, and 10 years and above in boys.
FOP is a condition that occurs in about 1 in 1,600,000 newborns, and about 800 people worldwide are known to have FOP, according to U.S. government data.
The company did not immediately respond to a Reuters request for comment on the drug’s price.
