FDA approves Nulojix

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for preventing organ rejection in kidney transplant patients, the agency said Wednesday.

The FDA approved Bristol-Myers Squibb’s Nulojix (belatacept), for preventing acute rejection in adult patients. The drug is approved for use with other immune system-suppressing drugs, specifically Novartis’ Simulect (basiliximab), Genentech’s CellCept (mycophenolate mofetil) and corticosteroids.

“Nulojix is a new option for kidney transplant patients,” FDA Office of Antimicrobial Products director Edward Cox said. “This new medication, used in combination with other immunosuppressants, helps control the immune system and prevents organ rejection in patients receiving kidney transplants.”

According to BusinessWeek, analyst John Boris said that while Nulojix’s market is limited, he expects the drug to have sales of about $350 million in 2015. About 17,000 to 18,000 kidney transplants are performed in the United States per year, while more than 86,000 patients were awaiting transplants as of March 2010, according to the National Institutes of Health.