US FDA approves first drug for GVHD

The US Food and Drug Administration (FDA) on Wednesday said it had approved Bristol Myers Squibb Co’s Orencia drug to prevent potentially fatal complications after stem cell transplants. .

This approval makes Orencia the first drug to prevent Acute Graft versus Host Disease, in which a donor’s immune cells attack the recipient’s body.

The regulator has removed the drug in combination with certain immunosuppressants for use in adults and children two years of age and older receiving a stem cell transplant from an unrelated donor.

The FDA initially approved the drug in 2005 for the treatment of rheumatoid arthritis in adults and later removed it for several other conditions as well.

(Reporting by Amruta Khandekar; Editing by Aditya Soni)


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