Roche's Zenapax Gets First Approval For Transplants

Hoffmann-La Roche has been given approval in the USA to market Zenapax(daclizumab), a humanized monoclonal antibody, in combination with ciclosporin and corticosteroids for the prophylaxis of acute organ transplant rejection in patients receiving kidney transplants. This is the first approval for the product, although it has been filed in most major markets worldwide, including Europe and Canada.

A spokeswoman for Roche said that the product would be launched onto the market in the week of December 15 and it was due to hit the shelves as the Marketletter went to press. The average wholesale price for Zenapax is $6,800 for five doses. The antibody is given in an initial dose of 1mg/kg 24 hours pretransplant, and the four remaining doses are given at intervals of 14 days.

Roche licenses Zenapax from Protein Design Labs of California, which will receive royalties on sales. It is the first of PDL's products to reach the market. The antibody is 90% human and 10% murine and targets the alpha subunit (p55 alpha, CD25 or Tac) of a high-affinity receptor on activated T cells which binds interleukin-2.