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news.The FDA has requested additional data to support Chiron Corporation's new drug application for Pulminiq, an experimental lung transplant drug designed to help prevent organ rejection.
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Although US regulators deemed Chiron’s application to be “approvable”, an additional pre-approval study was said to be required to confirm the efficacy of the drug.
Chiron is seeking an indication for the drug to increase survival and prevent chronic rejection in patients receiving allergenic lung transplants, in combination with standard immunosuppressive therapy.
“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 of Chiron Biopharmaceuticals. “We will carefully review our options before making any decisions regarding the product.”
Chiron announced the submission of the NDA in October 2004, and was granted priority review designation.