Chiron Corporation has submitted a New Drug Application (NDA) to the US FDA for marketing approval of Pulminiq (cyclosporine, USP) inhalation solution.
Chiron is seeking an indication for the increase in survival and prevention of chronic rejection in patients receiving allogeneic lung transplants, in combination with standard immunosuppressive therapy. Pulminiq could be the first immunosuppressant approved for this indication, release from Chiron said.
"Lung-transplant patients continue to suffer rejection rates substantially higher than those for patients receiving other organ transplants. If approved, Pulminiq would be a major breakthrough in treatment for lung-transplant patients, fulfilling an unmet medical need," said Craig Wheeler, president, Chiron BioPharmaceuticals.
"Despite the medical community's best efforts, long-term survival rates for patients receiving lung transplants have not improved over the last 10 years," said Aldo Iacono, associate professor of medicine and surgery in the division of pulmonary, allergy and critical care medicine, University of Pittsburgh School of Medicine, and principal investigator of the clinical studies used to support the Pulminiq NDA submission. "The potential for cyclosporine inhalation solution to prevent chronic rejection and increase survival is a very important step forward. Because of the patients who participated in our studies, we may have the opportunity to help many others," he added.
Pulminiq contains 300mg/4.8mL cyclosporine, USP for administration by inhalation. Pulminiq delivers cyclosporine directly to the lungs, achieving greater drug concentration at the rejection site than intravenous or oral cyclosporine. Cyclosporine, an immunosuppressant, has previously been approved in other products as a standard treatment for chronic rejection of kidney, liver and heart allogeneic transplants.
In April 2003, Chiron acquired from Novartis exclusive worldwide commercial development and marketing rights for Pulminiq, then referred to as aerosolized cyclosporine. Chiron received orphan drug designation from the FDA for Pulminiq in November 2003. The NDA for Pulminiq is supported by more than 12 years of data from clinical studies in lung-transplant patients conducted at the University of Pittsburgh.
Currently available immunosuppressant regimens have not been effective in reducing the incidence of chronic rejection or prolonging survival. Compared to other types of organ transplants, survival for lung transplantation has not improved appreciably in the last 10 to 15 years.
According to the International Society for Heart and Lung Transplantation 2004 registry data of lung transplants performed between January 1988 and June 2002, one-year survival remains about 75 per cent in the current era (transplants performed between January 1998 and June 2002). At five years, survival continues to be around 50 per cent, no better than it was in the late 1980s and early 1990s, and is now significantly less that seen after other solid organ transplants. Obliterative bronchiolitis, or chronic rejection, remains a cause of significant numbers of deaths after lung transplantation.