FDA Approves Bristol-Myers' Kidney Transplant Drug Nulojix - Update

[okarol]

FDA Approves Bristol-Myers' Kidney Transplant Drug Nulojix - Update
6/15/2011 7:40 PM ET
(RTTNews) - Bristol-Myers Squibb Co. (BMY: News ), said Wednesday the U.S. Food and Drug Administration has approved its Nulojix to prevent organ rejection in adult patients who have had a kidney transplant.

The FDA approved Nulojix to be used with other immunosuppressants (medications that suppress the immune system), such as basiliximab, mycophenolate mofetil, and corticosteroids.

According to Organ Procurement and Transplantation Network, over 89,000 patients are waiting for a kidney transplant in the U.S.

Nulojix is a type of drug called a selective T-cell costimulation blocker. Without immunosuppression, the body can reject a transplanted organ because the immune system recognizes the new organ as foreign. By preventing rejection, Nulojix, given through 30 minute intravenous infusions, works with other immunosuppressants to keep the new kidney working.

Companies that offer similar medications include Novartis AG (NVS), whose 'Zortress' had first-quarter sales of $42 million, an increase of 24 percent from the prior year. Roche Holding AG's (RHHBY.PK) CellCept (mycophenolate mofetil) had sales of 280 million Swiss francs, a 14 percent decline due to patent expiry in the U.S.

Bristol-Myers' Nulojix was evaluated in two Phase-3 studies that enrolled more than 1,200 patients and compared two dose regimens of Nulojix with another immunosuppressant, cyclosporine.


Despite its effectiveness and safety profile, Nulojix 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. Another Warning relates to an increased risk of serious infections and other cancers.

BMY closed Wednesday's regular trade at $27.42, up $0.27 or 0.98%, on a volume of 8.4 million shares on the NYSE. In after hours, the stock gained $0.19 or 0.69%.

   by RTT Staff Writer

http://www.rttnews.com/Content/BiotechStory.aspx?Id=1647268&Category=FDAPanel

[Chris]

Odd name, who comes up with these brand names?   
Add an n to last part of name and you get jinx, not good.   Not sure how to pronounce this name and drug companies should think aboutthat to make it easier for patients.