Regulators in the USA have given the green light to Bristol-Myers Squibb’s Nulojix for kidney transplant patients.
The US Food and Drug Administration has approved Nulojix (belatacept) to prevent acute organ rejection in adults who have undergone a kidney transplant. The drug, which is a selective T-cell costimulation blocker given through 30 minute intravenous infusions, can be used with other immunosuppressants, specifically basiliximab, mycophenolate mofetil and corticosteroids.
The approval is based on data from two Phase III studies involving more than 1,200 patients and compared two dose regimens of Nulojix with another immunosuppressant, cyclosporine. These trials demonstrated that the recommended Nulojix regimen is safe and effective for the prevention of acute organ rejection.
Bristol-Myers Squibb has suffered a setback with the news that regulators in the USA want more information on its organ transplant drug belatacept, despite an advisory panel backing the treatment in March.
The pathway to approval has not been the smoothest and in May 2010, the FDA issued a complete response letter for belatacept, despite the agency’s Cardiovascular and Renal Drugs Advisory Committee voting 13 to five in favour of approval. The FDA wanted to see 36-month data from the studies, while the original Biologics License Application only included 24-month data.
B-MS noted that other requests raised in the letter primarily related to information about the manufacturing of belatacept and the firm's proposed risk evaluation and mitigation strategy. The drug was to be made at B-MS' facility in Manati, Puerto Rico about which the FDA issued a warning letter over violations which have now been resolved.
Nulojix carries a boxed warning for an increased risk of developing post-transplant lymphoproliferative disorder, a type of cancer where white blood cells grow out of control after an organ transplant. Another boxed warning, which is also on the labels of other immunosuppressants, warns of an increased risk of serious infections and other cancers.