Bristol-Myers Squibb Company (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) approved NULOJIX, the first selective T-cell costimulation blocker indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant, in combination with basiliximab induction, mycophenolate mofetil (MMF), and corticosteroids. NULOJIX should only be used in patients who are EBV seropositive. Use of NULOJIX for prophylaxis of organ rejection in transplanted organs other than kidney has not been established. NULOJIX will be available as 250 mg lyophilized powder. The efficacy and safety of NULOJIX in adult de novo kidney transplant patients was studied in two 3-year, phase 3, open-label, randomized, multicenter, active-controlled studies (BENEFIT and BENEFIT-EXT).
“Selective T-cell costimulation blockade represents a new mechanism for the prevention of rejection in adult kidney transplant patients.”
"The approval of NULOJIX exemplifies our company's commitment to innovate in the areas of serious disease and biologics drug development," said Lamberto Andreotti, Chief Executive Officer, Bristol-Myers Squibb.