The FDA says Chiron's experimental therapy to prevent lung transplant rejection -- Pulminiq -- is "approvable," but needs new studies to prove its effectiveness to regulators. An FDA advisory panel said last June that the therapy seemed safe but questioned whether the trial included enough subjects to prove it was effective. Pulminiq is an inhaled version of cyclosporine, which is already approved for use in preventing the rejection of organ transplants. Chiron acquired Pulminiq from Novartis.
"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."
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