INOpulse regulatory update
Bellerophon said FDA could approve INOpulse for pulmonary arterial hypertension (PAH) as early as 2020 after the agency accepted changes to INOpulse’s Phase III program. Bellerophon will now replace the planned Phase III INOvation-2 trial in 282 patients with a crossover Phase III withdrawal trial in about 40 patients. The change allows the withdrawal trial and the ongoing Phase III INOvation-1 trial to support an NDA and be “conducted on near parallel timelines.” The company had expected INOvation-2 would follow INOvation-1, which would lead to a regulatory decision in 2022. Bellerophon plans to begin the withdrawal trial in 2H17, with an interim analysis in 2H18. The company expects an interim analysis of data from INOvation-1 by year end...