Zenapax meeting

FDA panel pushes the limits of labeling

GAITHERSBURG, Md. - The Biological Response Modifiers Advisory Committee's discussion of Protein Design Lab Inc.'s Zenapax for prevention of kidney transplant rejection took an unexpected turn on Friday when members took it upon themselves to discuss the possibility of extending the label to include all vascularized solid organs.

Indeed, half the committee members voted to recommend extending the label beyond kidney transplants to include other organs. Although the FDA is not likely to include other organs on the initial Zenapax label, the committee's discussion and vote will make it far easier to have other organs added in the future, and it may affect the development strategies for prophylactic agents against transplant rejection.