US FDA approves Bristol-Myers Squibb's Nulojix for kidney transplant patients

In a much anticipated move following a positive 13 to five advisory committee vote (The Pharma Letter March 3), the US Food and Drug Administration late yesterday said it had approved drug major Bristol-Myers Squibb’s (NYSE: BMY) Nulojix (belatacept) to prevent acute rejection in adult patients who have had a kidney transplant. The drug is approved for use with other immunosuppressants - specifically basiliximab, mycophenolate mofetil and corticosteroids.

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

$650 million sales in 2016 forecast by analyst