Date: 2012-03-06
Type of information:
Product name: Nulojix®
Compound: belatacept
Therapeutic area:
Action mechanism: Belatacept is a selective T-cell costimulation blocker. Belatacept binds to CD80 and CD86 on antigen presenting cells. As a result, belatacept blocks CD28 mediated co-stimulation of T cells inhibiting their activation, thus leading to immunosuppression.
Company: BMS (USA)
Disease: intended in combination with corticosteroids and a mycophenolic acid for prophylaxis of graft rejection in adults receiving a renal transplant
Latest news: * On June 15, 2011, the FDA approved 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® was evaluated in two open-label, randomized, multicenter, controlled Phase 3 studies that enrolled 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. The drug carries a Boxed Warning for an increased risk of developing post-transplant lymphoproliferative disorder (PTLD), a type of cancer where white blood cells grow out of control after an organ transplant. The risk of PTLD is higher for transplant patients who have never been exposed to Epstein-Barr virus (EBV), the cause of mononucleosis. Transplant patients who have not been exposed to EBV have more difficulty mounting an effective immune response to the virus if they get infected after transplant; typically they get exposed to the virus at time of transplant, as it is carried in around 80 percent of donated organs. Patients should be tested for EBV and should only receive Nulojix® if the test shows they have already been exposed to EBV. Another Boxed Warning on the Nulojix® label, as well as labels of other immunosuppressants, warns of an increased risk of serious infections and other cancers.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2011-06-15
UE authorization: 2011-06-17
Favourable opinion UE: 2011-04-14
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
