Washington.– Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) has approved Orencia® (abatacept), the first selective modulator of a co-stimulatory signal required for full T-cell activation, for the treatment of rheumatoid arthritis (RA).  

Orencia is indicated for reducing the signs and symptoms of RA, inducing major clinical response, slowing the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs), such as methotrexate (MTX) or tumor necrosis factor (TNF) antagonists.  

Orencia may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists. Orencia should not be administered concomitantly with TNF antagonists and is not recommended for use concomitantly with anakinra.  

"Bristol-Myers Squibb is committed to discovering and developing innovative medications that address areas of significant unmet need," said Peter R. Dolan, chief executive officer, Bristol-Myers Squibb.  

"There is clearly a need for more therapies for rheumatoid arthritis, and Orencia has the potential to help many people with this serious disease. Orencia is our first internally-discovered biologic and it further diversifies our pharmaceutical portfolio."  

Orencia was studied in patients with an inadequate response to DMARDs. Specifically, it is the first approved agent to demonstrate efficacy and safety in patients with an inadequate response to TNF antagonists, as well as those with an inadequate response to MTX.  

Methotrexate is the most widely used non-biologic DMARD for RA and TNF antagonists are the most widely used biologic therapies for RA. Orencia is also the first in a new class of agents for the treatment of RA that selectively modulates a co-stimulatory signal required for full T-cell activation.  

"In clinical trials, Orencia significantly reduced the signs and symptoms of rheumatoid arthritis among patients who had inadequate response to DMARDs such as methotrexate and/or anti-TNF therapy when compared to placebo," said Mark Genovese, M.D., associate professor of medicine at the Stanford University School of Medicine, Palo Alto, CA.  

“Rheumatoid arthritis is a very serious disease and it is critical that we continue to add therapies to our armamentarium."