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FDA Approves Bristol-Myers Kidney Transplant Drug

U.S. health regulators approved on Wednesday a Bristol-Myers Squibb Co drug to prevent organ rejection in adult patients who have undergone a kidney transplant.

The Food and Drug Administration said it approved the drug, Nulojix, for use along with other drugs designed to suppress the immune system, such as corticosteroids.

Without immunosuppression, the body can reject a transplanted organ as the immune system sees the new organ as a foreign body and attacks it.

Nulojix, known chemically as belatacept, belongs to a class of drugs known as selective T-cell costimulation blockers. Administered via 30 minute intravenous infusions, Nulojix works with other immunosuppressants to keep the new kidney working.

The drug's label will carry a boxed warning for an increased risk of developing a type of cancer called post-transplant lymphoproliferative disorder in which white blood cells grow out of control after an organ transplant.

Some Wall Street analysts have said Nulojix sales could be somewhat limited by the need for monthly intravenous infusions, given that standard anti-rejection treatment cyclosporine is an oral drug.