Chiron Corporation (CHIR) Release: FDA Requests Additional Data On PULMINIQ(TM) (Cyclosporine, USP) Inhalation Solution; Agency Action Letter States That PULMINIQ Is "Approvable" But Additional Study Is Required
10/19/2005 5:09:36 PM
EMERYVILLE, Calif.--(BUSINESS WIRE)--July 15, 2005--Chiron Corporation (NASDAQ:CHIR) today announced that the company has received an action letter from the U.S. Food and Drug Administration (FDA) stating that the company's New Drug Application (NDA) for PULMINIQ(TM) (cyclosporine, USP) inhalation solution is "approvable" but that an additional pre-approval study is required to confirm the efficacy of the drug. In the NDA for PULMINIQ, Chiron is seeking an indication to increase survival and prevent chronic rejection in patients receiving allogeneic lung transplants, in combination with standard immunosuppressive therapy. Chiron is evaluating possible next steps for PULMINIQ.
"Chiron in-licensed PULMINIQ knowing the significant regulatory challenges associated with a single-center trial with a small patient population. We took on these challenges because we believe strongly in the data for PULMINIQ," said Craig Wheeler, president, Chiron BioPharmaceuticals. "We will carefully review our options before making any decisions regarding the product."