drug for lung transplant patients may be safe, but members of a Food and Drug Administration advisory panel aren't sure its effectiveness makes it worthy of approval.
The Emeryville, Calif., company's Pulminiq inhalation solution came before the FDA's Pulmonary-Allergy Drugs Advisory Committee on Monday for a review of the drug's safety and efficacy. The committee declared that the drug is safe, but members disagreed on whether there was enough data to show that it's effective, voting 8-8 on the efficacy issue.
The panel wasn't asked to vote on whether to recommend approval of the treatment. Pulminiq is a solution that contains the drug cyclosporine, which is already approved and is part of a standard of care for kidney and liver transplant patients.
In a trial of 56 patients, in which 26 received Pulminiq and 30 received a placebo, patients were given the drug three times a week for two years after the maximum tolerated dose was determined. Clinical data submitted with the new drug application to the FDA showed that the drug reduced the risk of death by 79% and lowered the risk of chronic rejection or death by 72% for patients receiving Pulminiq vs. those getting the placebo.
If approved, Pulminiq would be the first drug indicated specifically for the treatment of lung-transplant patients. Chiron said it expects to hear the FDA's final decision by July 14. Shares were up 17 cents to $37.82 Tuesday morning.