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Bristol-Myers Squibb gets FDA breakthrough therapy status for Orencia to prevent GvHD

Bristol-Myers Squibb (BMS) has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its Orencia (abatacept) to prevent moderate to severe acute graft-versus-host disease (GvHD) in hematopoietic stem cell transplants from unrelated donors.

GvHD is a potentially life-threatening medical complication, which can affect patients receiving such transplants to treat certain genetic diseases and haematologic cancers.

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

The designation was provided based on the results from an investigator-initiated trial supported by the company.

The phase 2 study evaluated the impact of Orencia 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.

Orencia was approved in the US to reduce signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.

It was also approved to reduce signs and symptoms in patients two years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis. In addition, Orencia was approved to treat adult patients with active psoriatic arthritis.

Bristol-Myers Squibb Orencia development lead Dr Brian Gavin said: “We are excited about the potential of ORENCIA to improve outcomes for patients receiving unrelated stem cell transplants.

“We believe the data could lead to an expansion of the donor pool for stem cell transplants in some patient populations where fully matched unrelated donor transplants have rarely been available.

“We look forward to working with the FDA and making ORENCIA the first approved therapy for the prevention of acute GvHD.”

In November, Bristol-Myers Squibb completed the acquisition of US-based biotechnology company Celgene in a cash-cum-stock deal worth around $74bn.

In August, BMS agreed to sell the global rights of Celgene’s psoriasis drug Otezla (apremilast) to Amgen for $13.4bn, as part of the regulatory approval process related to the transaction.

BMS is involved in the discovery, development and commercialisation of advanced medicines for the treatment of serious diseases.

5 Dec 2019


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