FDA’s review of Belacept expected soon (NYSE:BMY)
Belacept is a pharmaceutical agent that is being developed by the Brystol-Myers Squibb Company (NYSE:BMY), often called Brystol-Myers for short. The company submitted a biologic licensing application to the United States of America’s toughest regulator, the Food & Drug Administration (FDA), in the early 2009, to get the regulator’s approval for using belatacept during kidney transplantation. And on September 03, 2009, the company disclosed to its stakeholders that the submitted biological application was successful in getting accepted by the FDA. This meant that the FDA had filed the application and would not conduct a thorough review of the submitted information on belatacept. Based on this review, the FDA would decide whether the belatacept could be used during the transplantation of kidneys. This review would also be conducted by the Cardiovascular and Renal Drugs Advisory Committee of the FDA and is expected to begin on March 1, 2010.
The company also announced that the FDA would complete the review and announce its decision by May. At present, the expected Prescription Drug User Fee Act (PDUFA) date is May 1, 2010, though it may change in the future.
The agent, belatacept, is currently in its Phase III stage – which is dealing with the drug’s safety and effectiveness in preventing the rejection of the kidney graft during kidney transplantation. The body’s immune system often rejects the kidney graft and thus makes kidney transplantation impossible. Belatacept aims to be helpful in these instances. In addition, it will also make the kidney work normally.
So, how does the belatacept work? Since it is made of protein, it can easily attach to the antigen cells of the immune system, and thus prevent the signal of the immune system from reaching the T-cells. As a result, the T-cells become unable to reject the kidney graft.
The company believes that the acceptance of the biologic licensing application is a significant step to getting a novel pharmaceutical product into the market. A key person in the company is Elliott Sigan, M.D., Ph.D, who is the Present, the Chief Scientific Officer and also the Executive Vice President of Brystol Myerrs. After the news of the FDA acceptance was released, he said,
“Belatacept has the potential to address significant unmet medical needs of transplant patients. We are pleased the FDA has accepted our submission and we look forward to continuing to work with the agency.”
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