Pulminiq Is “Approvable” At FDA; Confirmatory Trial Is Needed
This article was originally published in The Pink Sheet Daily
Executive Summary
Chiron will evaluate next steps before making any decisions regarding the aerosolized cyclosporine therapy. FDA is requiring a clinical trial to confirm the efficacy of Pulminiq demonstrated in a single Phase II trial.
You may also be interested in...
Pulminiq Advisory Cmte. Splits On Survival Benefit In Lung Transplant
FDA committee members differ on whether Chiron should be required to conduct another trial prior to approval to confirm the suggested survival benefit seen in a lung transplant trial of aerosolized cyclosporine. Chiron points to difficulty in conducting a second placebo-controlled trial.
Pulminiq Survival Benefit May Be Due To Patient Imbalances, FDA Says
Imbalance in numbers of single and double lung transplant patients could have driven survival difference, FDA says. The agency’s Pulmonary-Allergy Drugs Advisory Committee will review Chiron’s Pulminiq for lung transplant rejection on June 6.
Teva Says The Time Is Right For Two Big Immunology Biosimilar Launches
US market access senior VP Tom Rainey talks to Scrip about the upcoming launches of biosimilar versions of Humira and Stelara.