Bristol-Myers Squibb gets EU approval for Nulojix for kidney transplant rejection

The European Commission yesterday granted marketing authorization for US drug major Bristol-Myers Squibb’s (NYSE: BMY) Nulojix (belatacept), a new biologic agent for the prophylaxis of graft rejection in adult patients receiving a kidney transplant. The drug is expected to become commercially available in Europe in the coming months, said B-MS.

Earlier this month, the US Food and Drug Administration approved Nulojix to prevent acute rejection in adult patients who have had a kidney transplant (The Pharma Letter June 16). The drug is approved for use with other immunosuppressants - specifically basiliximab, mycophenolate mofetil and corticosteroids. Swift uptake of the drug is not expected because of the significantly higher rate of acute rejection seen with belatacept," said Leerink Swann analyst Seamus Fernandez in a recent investment note. He forecast sales of $50 million in 2010 and $650 million by 2016. Some analysts have suggested that use of Nulojix could be tempered due to its 30-minute infusion formulation, given that the current standard treatment is cyclosporine, which is an oral drug.

Belatacept is the first molecule with a new mechanism of action approved in a decade in kidney transplantation, noted B-MS. By acting selectively on the immune system to prevent graft rejection, belatacept helps safeguard renal function, which is increasingly recognized as a key predictor of long term outcomes in kidney transplant recipients, impacting both patient and graft survival.