USA – The US Food and Drug Administration (FDA) has given Orencia approval as a preventative therapy for acute graft-versus-host disease (GVHD) in combination with certain immunosuppressants.

Orencia is the first drug to be approved as a graft-versus-host disease (GVHD) preventative. The blessing is extended to people aged 2 and up who are undergoing bone marrow or stem cell transplants from an unrelated donor.

Bristol Myers Squibb’s Orencia is putting together an impressive second act in its twilight. The rheumatoid arthritis medication, which was first approved in 2005, received a boost in 2017 when it was approved for psoriatic arthritis.

GVHD occurs during a stem cell transplant when donor T cells, which are intended to attack cancer cells, instead attack healthy tissues and organs.

The skin, liver, and gastrointestinal tract are the most common targets. It affects 30% to 70% of transplant patients, depending on the donor, transplant type, and other factors, and can be fatal.

While stem cell transplants are effective in the treatment of leukemias and other hematological cancers, patients who receive transplants from unrelated or mismatched donors are at a high risk of developing acute HVGD.

Acute graft versus host disease can affect different parts of the body and become a serious post-transplant complication,” Richard Pazdur, M.D., director of the FDA’s oncology center of excellence, said in a release.

By potentially preventing the disease, more patients may successfully undergo bone marrow or stem cell transplantation with fewer complications.”

Orencia is an immunomodulator that works by binding to and inhibiting proteins involved in co-stimulation, a signaling process that causes T cells to attack.

The most recent approval was based on a phase 2 trial of 186 patients, which demonstrated that adding Orencia to standard prophylaxis (a calcineurin inhibitor plus methotrexate) resulted in significantly higher acute GVHD-free survival at 180 days after transplant for those in the mismatched unrelated donor arm.

Orencia provided numerically higher acute GVHD-free survival in the matched unrelated arm. According to BMS, a real-world analysis yielded similar results.

Orencia has grown in popularity since its initial approval. In 2012, it became a blockbuster (PDF). The company then generated US$2.71 billion in sales in its first full year following the psoriatic arthritis green light (2018).

Sales increased to US$3.16 billion last year, and earnings reports for the first three quarters of this year show no slowdown, with US$2.44 billion earned through the first three quarters, according to article published by Fiercepharma.

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