PulminiqTreatment for Lung-Transplant Rejection
Chiron Receives FDA Priority Review Designation for New Drug Application for Pulminiq -- Cyclosporine, USP-- Inhalation Solution
Agency Sets Six-Month Review Period for New Treatment for Lung-Transplant Patients
EMERYVILLE, Calif., December 15, 2004 -- Chiron Corporation (Nasdaq:CHIR) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for marketing approval of Pulminiq (cyclosporine, USP) inhalation solution. The NDA also has been granted priority review designation, which sets an agency action letter due date of six months from the time of filing. Chiron announced the NDA submission for Pulminiq on October 14, 2004.
"Because the potential value of this therapy to improve the survival of and prevent chronic rejection in lung-transplant patients is significant, we are very pleased that the FDA has decided to grant Pulminiq a priority review," said Craig Wheeler, president, Chiron BioPharmaceuticals. "Approximately 4,000 patients in the United States are currently awaiting lung transplants, and Pulminiq could significantly benefit those fortunate enough to receive transplants."
Priority review designation is granted to products that would be a significant improvement compared to marketed products in the treatment, diagnosis or prevention of a disease. Chiron is seeking an indication for Pulminiq for the increase in survival and prevention of chronic rejection in patients receiving allogeneic lung transplants, in combination with standard immunosuppressive therapy. Pulminiq would be the first immunosuppressant approved for this indication.
The NDA for Pulminiq is supported by clinical data from subjects exposed to the drug for at least 2 years. A pivotal randomized double-blinded, placebo-controlled trial of cyclosporine inhalation solution (CyIS) conducted at the University of Pittsburgh enrolled patients who underwent single-lung or double-lung transplants and were on standard immunosuppressive therapies. Data from the pivotal trial demonstrates a 79 percent decrease in the risk of death for patients receiving Pulminiq compared to patients receiving placebo during the study period. Fourteen (46.7 percent) of the placebo-treated patients died prior to study closure, as compared to three (11.5 percent) of the CyIS-treated patients. The estimated survival duration hazard ratio was 0.213, which equates to a 79 percent decrease in the risk of death for patients receiving CyIS compared to patients receiving placebo during the study period. Overall there were 18 (60 percent) patients with histologically proven bronchiolitis obliterans or death in the placebo arm versus five (19 percent) in the CyIS arm (P=0.003), and fewer CyIS-treated subjects died or developed bronchiolitis obliterans syndrome grade 1 or higher (39 percent of the CyIS-treated subjects versus 70 percent of the placebo-treated subjects; P=0.020). However, the rate of grade 2 or higher acute rejections was 7.9 percent higher in the placebo arm than in the CyIS arm (P=0.73) and did not appear to have an effect on the development or prevention of acute rejection. Side effects included probable treatment-related bronchospasm manifested by exacerbated dyspnea and airway irritation.
About Pulminiq (Cyclosporine, USP) Inhalation Solution
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.
About Lung-Transplant Rejection
Rejection is the process by which an organ transplant recipient's immune system recognizes, becomes sensitized against and attempts to eliminate the foreign antigens of the donor organ. The lung is one of the most vulnerable organs to rejection. Despite the use of immunosuppression therapy, acute rejection can and often does occur. Later, post-transplantation, chronic rejection may also occur. 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 percent in the current era (transplants performed between January 1998 and June 2002). At five years, survival continues to be around 50 percent, no better than it was in the late 1980s and early 1990s, and is now significantly less than seen after other solid organ transplants. Obliterative bronchiolitis, or chronic rejection, remains a cause of significant numbers of deaths after lung transplantation.
Chiron delivers innovative and valuable products to protect human health by advancing pioneering science across the landscape of biotechnology. The company works to deliver on the limitless promise of science and make a positive difference in people's lives.
For more information about Chiron, please visit www.chiron.com.
Posted: December 2004
- FDA Requests Additional Data on Pulminiq (Cyclosporine, USP) Inhalation Solution; Agency Action Letter States that Pulminiq is ''Approvable'' But Additional Study is Required - July 15, 2005
- Chiron Submits New Drug Application for Pulminiq; Inhaled Form of Cyclosporine Could Be First Immunosuppressant Indicated for Chronic Lung-Transplant Rejection - October 14, 2004