“Nulojix, also known by the chemical name belatacept, is an alternative to some older immune suppressants, which cause headaches and nausea and, occasionally, kidney toxicity.”
“Bristol expects a Food and Drug Administration decision next week on one of the drugs, belatacept, which is designed to prevent organ rejection in patients receiving kidney transplants.”
“Next up for transplant drugs is Bristol-Myers Squibb's (NYSE: BMY) belatacept, which is awaiting”
“Food and Drug Administration (FDA) has accepted, for filing and review, the company's submission of a biologic license application for belatacept, which is in ongoing phase III development for use in kidney transplantation.”
“However, Bristol may be on the verge of introducing several new drugs that could alleviate the pressures, including skin-cancer treatment ipilimumab, diabetes drug dapagliflozin and organ-transplant drug belatacept.”
“He estimates belatacept, which Bristol proposes to sell under the brand Nulojix, could generate $600 million in annual sales in 2017.”
“Bristol spokeswoman Jennifer Mauer said Thursday the FDA is expected to make a decision by June 15 on belatacept and by Aug. 4 for the new Orencia formulation.”
“The New York-based company said it was required to resolve the issues before the FDA would consider approving belatacept and a version of rheumatoid arthritis drug Orencia, which can be injected.”
“Bristol-Myers Squibb said the PML case seen in the kidney study was in a "more intensive" regimen of belatacept, and is proposing to use a lower dose of the drug.”
“The agency said patients receiving belatacept had better-functioning kidneys, improved blood pressure and lower rates of diabetes.”
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