A US Food and Drug Administration advisory panel is set to convene on June 6 to determine whether Chiron’s Pulminiq (cyclosporine) should be approved for the treatment of lung transplantation.
Chiron is specifically seeking the green light for Pulminiq in combination with standard immunosuppressive therapy to increase survival and prevent chronic rejection in patients receiving lung transplants.
The committee’s discussion is likely to focus on additional analyses of pivotal data, which were submitted earlier this year to further support the application.
The product has already been granted fast-track approval status [[16/12/04d]], and Chiron claims that, should it win approval, Pulminiq would be the first immunosuppressant approved in this indication.
