(Reuters) – The U.S. Food and Drug Administration on Friday approved Celgene Corp’s Inrebic to treat certain rare forms of bone marrow cancer called myelofibrosis.
The treatment comes with a boxed warning, the drug regulator’s harshest, flagging concerns that include serious and fatal brain damage.
The approval comes when Bristol-Myers Squibb Co has agreed to buy Celgene for cash and stock in the largest pharmaceutical industry merger ever.
Myelofibrosis is a chronic disorder where scar tissue formation forces the production of blood cells to move from the bone marrow to the spleen and liver, causing organ enlargement.
Celgene’s Inrebic is a JAK inhibitor and works by blocking inflammation-causing Janus kinases enzymes.
Incyte Corp’s Jakafi, a JAK inhibitor, is already approved in the United States to treat certain bone marrow and blood disorders. Jakafi was first approved in the United States in 2011.
Inrebic was approved based on results from a trial of 289 patients with myelofibrosis where the drug was tested against a placebo.
Reporting by Aakash Jagadeesh Babu in Bengaluru; Editing by Shinjini Ganguli and Sriraj Kalluvila
