Pulminiq Inhaled Cyclosporine Approval Will Be Delayed
This article was originally published in The Pink Sheet Daily
Executive Summary
Chiron expects approval of the inhaled cyclosporine Pulminiq to be delayed by three months while FDA reviews additional analyses of pivotal data
|
Chiron expects approval of the inhaled cyclosporine Pulminiq to be delayed by three months while FDA reviews additional analyses of pivotal data. "The FDA has been reviewing Chiron's NDA submission and has requested additional analysis of the pivotal study," the company said. "Chiron believes that, as a result, the company's action letter date will be extended to July." The Pulminiq NDA for prevention of lung transplant rejection was submitted Oct. 14 and received a priority review (1 (Also see "Chiron Submits NDA For Inhaled Immunosuppressant Pulminiq For Lung Transplant" - Pink Sheet, 14 Oct, 2004.)). The original user fee deadline fell in April. While oral and I.V. cyclosporine are considered standard treatments for organ transplant rejection, Chiron says Pulminiq's aerosolized formula delivers the drug directly to the lungs, thereby achieving greater concentration at the rejection site. Pulminiq will be available to transplant patients prior to approval; FDA has granted Chiron clearance to provide the immunosuppressant through an early access program. Chiron will commence the program soon. Approval of Pulminiq would be a small bright spot on an otherwise bleak outlook for Chiron; the company's Fluvirin flu vaccine license has been suspended by U.K. authorities until GMP violations have been addressed (see 2 (Also see "Chiron’s Fluvirin Distribution Contracts Under Discussion" - Pink Sheet, 27 Jan, 2005.) ). - Kate Rawson |