(Reuters) – The U.S. Food and Drug Administration on Wednesday approved French drugmaker Ipsen’s bone disorder drug, making it the first treatment available to patients with the rare condition that causes abnormal bone growth, the company said.
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.
(Reporting by Bhanvi Satija, Sriparna Roy and Pratik Jain in Bengaluru; Editing by Shinjini Ganguli)
