The U.S. Food and Drug Administration (FDA) said on Wednesday it had approved Bristol Myers Squibb Co.'s drug Orencia to prevent a potentially fatal complication that could occur after a stem cell transplant.
The approval makes Orencia the first drug for the prevention of acute Graft versus Host Disease, in which the donor's immune cells attack the recipient's body.
The regulator has cleared the drug in combination with certain immunosuppressants for use in adults and kids aged two years and older who are undergoing stem cell transplantation from an unrelated donor.
The FDA originally approved the drug in 2005 for the treatment of adult rheumatoid arthritis and later also cleared it for certain other conditions.