The U.S. Food and Drug Administration said it approved the drug, called Arcalyst, for two rare disorders known as cryopyrin-associated periodic syndromes, which are marked by joint pain, rash and skin lesions and fever in children and adults.
WASHINGTON (Reuters) - U.S. regulators on Wednesday approved a new drug to be sold by Regeneron Pharmaceuticals Inc to treat certain chronic but rare inherited inflammatory disorders.
The U.S. Food and Drug Administration said it approved the drug, called Arcalyst, for two rare disorders known as cryopyrin-associated periodic syndromes, which are marked by joint pain, rash and skin lesions and fever in children and adults.
A more serious type can result in hearing loss.
The FDA cleared the drug under the orphan drug act, which gives companies exclusive marketing rights for seven years to encourage development of treatment for rare disorders.
!ADVERTISEMENT!About 300 people in the United States suffer from some form of the conditions, the FDA said. The drug blocks a signaling protein in the body that in excess can create inflammation.
(Reporting by Kim Dixon; editing by Carol Bishopric)
