European approval for BMS kidney transplant drug Nulojix
pharmafile | June 22, 2011 | News story | Sales and Marketing | BMS, EMA, Nulojix, transplant
European regulators have followed their US counterparts in granting marketing authorisation for a drug which aims to prevent kidney transplant patients rejecting their new organ.
Bristol-Myers Squibb’s selective T-cell costimulation blocker Nulojix (belatacept) was given a positive opinion by the CHMP in April and the European Commission has now given it the green light.
The FDA made its decision last week, after a period during which the manufacturer had been threatened with a block on approvals of Nulojix, among other new drugs, because of ongoing problems at a manufacturing facility in Puerto Rico.
The EC approval is for Nulojix in combination with corticosteroids and a mycophenolic acid, with a recommendation to add an interleukin-2 receptor antagonist at induction, for prophylaxis of graft rejection in adults receiving a renal transplant.
“As the first new biologic therapy approved for the prevention of graft rejection in kidney transplantation in a decade, Nulojix gives kidney transplant recipients a new innovative treatment option,” said Ron Cooper, BMS’s president, Europe.
In two phase III trials, BENEFIT and BENEFIT-EXT, the drug has similar rates of graft and patient survival versus standard treatment cyclosporine, but Nulojix has better preservation of renal function at one year, maintained over three years.
“What we see today with Nulojix is that it helps preserve kidney function after transplantation and we know that this is critical for patients to keep their graft healthier for longer,” Cooper added.
Around 18,000 kidney transplants were performed in the EU in 2009, although at the end of that year more than 50,000 Europeans still needed a transplant.
Preserving renal function after the organ has been transplanted can help avoid a return to dialysis and the need for another transplant.
Activated T cells are key movers in immunologic rejection, and Nulojix binds to CD80 and CD86 on antigen-presenting cells, blocking CD28 mediated co-stimulation of these cells.
The drug inhibits T lymphocyte proliferation and the production of the cytokines interleukin-2, interferon-g, interleukin-4 and TNF-a.
The overall safety profile of Nulojix is comparable to cyclosporine, but some patients taking Nulojix did suffer post-transplant lymphoproliferative disorder.
This risk was increased for those who were seronegative for the Epstein-Barr virus (EBV), so Nulojix is contraindicated for patients who are EBV-negative or whose serostatus is unknown.
Adam Hill
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