Although the US Food and Drug Administration advisory panel, which yesterday assessed Chiron’s submission for Pulminiq (cyclosporine), backed the product’s safety, it was split on whether it there were sufficient efficacy data to support FDA approval for increasing survival in lung transplant patients.
The eight votes to eight recorded yesterday reflected uncertainty about whether the survival difference seen in a 56-patient study was actually due to Pulminiq. The advisory committee was not asked to vote on whether to recommend approval.
Pulminiq is an inhaled formulation of cyclosporine, an FDA-approved drug that has been part of the standard of care for heart, kidney and liver transplant patients for more than 20 years. Chiron is seeking an indication to increase survival and prevent chronic rejection in patients receiving allogeneic lung transplants, in combination with standard immunosuppressive therapy. The firm notes that data filed with the US regulator showed a 79% decrease in the risk of death and a 72% decrease in the risk of chronic rejection or death for patients receiving Pulminiq compared to patients receiving placebo.
Chiron acquired exclusive worldwide commercial development and marketing rights for Pulminiq from Novartis in April 2003. It was granted priority review designation, establishing a six-month FDA review period. However, in January 2005, the FDA requested additional analysis of the pivotal study, thereby extending the review period. Chiron is now expecting a definitive FDA decision on whether to approve potentially the first therapy indicated specifically for patients living with lung-transplants, by the middle of July.
Approximately 1,100 lung transplants are performed each year in the US but only 45% of lung transplant recipients will be alive after five years, in spite of aggressive care. By contrast, 70% to 90% of heart, kidney and liver transplant recipients will be alive at five years.
