From rxpgnews.com
Aerosolized Cyclosporine Shows Significant Results in Chronic Rejection of Allogenic Lung Transplants
By Akanksha, Pharmacology Correspondent,
Mar 24, 2005 - 9:21:38 AM
The Pulmonary-Allergy Drugs Advisory Committee will review Chirons aerosolized cyclosporine Pulminiq for lung transplantation June 6.
The committee discussion likely will focus on additional analyses of pivotal data.
Chiron confirmed that FDA extended aerosolized cyclosporines priority review deadline of April 15 by 90 days following the firms submission of additional analyses earlier this year.
The company had been expecting the 90-day extension following FDAs request for further analysis of the NDAs pivotal trial.
The aerosolized cyclosporine NDA (50-799) includes a single pivotal trial that showed significant results in chronic rejection of allogenic lung transplants, but not in acute rejection.
Chiron is seeking approval for use of aerosolized cyclosporine in combination with standard immunosuppressive therapy to increase survival and prevent chronic rejection in patients receiving allogenic lung transplants.
This would be the first immunosuppresant approved for the indication, Chiron said.
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