FDA Advisory Committee to Review Chiron's Pulminiq
The safety and efficacy of Chiron's immunosuppressant candidate Pulminiq will
be reviewed by the FDA's Pulmonary-Allergy Drugs Advisory Committee in a June
Chiron submitted a new drug application for Pulminiq (cyclosporine, USP) inhalation solution in October 2004 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, according to Chiron.
Chiron acquired exclusive worldwide commercial development and marketing rights for Pulminiq originally developed by Novartis in April 2003. The drug candidate was granted priority-review status last December.
The Pulmonary-Allergy Drugs Advisory Committee meeting is scheduled for June 6 at the Center for Drug Evaluation and Research's office in Rockville, Md.
For more information, go to http://www.fda.gov/oc/advisory/accalendar/2005/cder12545d060605.html.