FDA OKs Bristol Myers' Orencia in Acute Graft-Vs-Host Disease
December 15 2021 - 12:44PM
Dow Jones News
By Colin Kellaher
Bristol Myers Squibb Co. has won Food and Drug Administration
approval for expanded use of the blockbuster arthritis drug Orencia
as the first U.S. drug for the prevention of moderate-to-severe
acute graft-versus-host disease.
The agency said the approval covers Orencia in combination with
certain immunosuppressants for patients two years of age or older
undergoing hematopoietic stem-cell transplantation from an
unrelated donor.
Acute graft-versus-host disease is a potentially fatal
complication that occurs when donor bone marrow or stem cells
attack the graft recipient.
Bristol Myers reported revenue of $2.44 billion for the first
nine months of the year for Orencia, which was previously approved
in the U.S. to treat adult rheumatoid arthritis, polyarticular
juvenile idiopathic arthritis and adult psoriatic arthritis.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
December 15, 2021 12:29 ET (17:29 GMT)
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