Research & Development
US FDA grants breakthrough therapy status to Bristol-Myers Squibb's Orencia
6 December 2019 -

The US Food and Drug Administration (FDA) has granted breakthrough therapy status to United States-based Bristol-Myers Squibb's Orencia (abatacept) to prevent moderate to severe acute graft-versus-host disease (GvHD) in hematopoietic stem cell transplants from unrelated donors, it was reported yesterday.

The product is an immunomodulator that disturbs the continuous cycle of T–cell activation, which indicates rheumatoid arthritis (RA).

The FDA designation was granted based on the results of an investigator-initiated trial supported by the company. The phase two study assessed the effect of the product on the prevention of severe acute GvHD, when combined with a standard GvHD prophylactic regimen administered to patients with hematologic malignancies receiving a stem cell transplant from an unrelated, HLA-matched or mismatched donor. It was also approved to decrease signs and symptoms in patients two years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis. In addition, the product was approved to treat adult patients with active psoriatic arthritis.

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