Roche's Zenapax Gets Backing Of FDA Panel

Roche's anti-TAC antibody Zenapax (dacliximab) has been recommended forapproval for the prevention of acute first-time organ rejection episodes in kidney transplant patients by the US Food and Drug Administration's Biological Response Modifiers Advisory Committee. The panel voted unanimously that the humanized antibody should be marketed for adults, and also voted nine to three not to exclude pediatric kidney transplants from the labeled indication.

Roche licenses the drug from Protein Design Labs of the USA, and has exclusive, worldwide marketing rights to the product. It has also filed for approval for Zenapax in the European Union and Canada. The company is currently applying to appropriate authorities to change the generic name of the product to daclizumab.

Roche will pay royalties on sales of Zenapax to PDL, and analysts have estimated that Zenapax could turn over anywhere between $100 million and $250 million a year after five years on the market. Zenapax will consolidate Roche's transplantation franchise, spearheaded by CellCept (mycophenolate mofetil) for prevention of kidney transplant rejection, which is also in trials for liver and heart transplants.