Pulmonary hypertension is associated with higher in-hospital mortality, morbidity, length of stay, and health care utilization in patients admitted to the hospital with an acute exacerbation of COPD.
The sNDA is supported by data from the multicenter, double-blind, placebo-controlled phase 3 INCREASE study.
Treatment with LIQ861, an inhaled dry-powder form of treprostinil, was associated with significant improvements in several clinical and quality of life measures in patients with pulmonary arterial hypertension.
Treatment with inhaled nitric oxide has been shown to have both pulmonary and antiviral benefits.
Inhaled nitric oxide 45 mcg/kg of ideal body weight per hour was effective for improving physical activity in patients at risk for pulmonary hypertension associated with fibrotic interstitial lung disease.
Mallinckrodt announced that the phase 4 observational registry study evaluating INOmax® (nitric oxide) gas, for inhalation, in preterm neonates with pulmonary hypertension was stopped early due to “achievement of the pre-specified primary outcome measure, noninferiority.”
United Therapeutics announced additional positive data from the phase 3 FREEDOM-EV trial of Orenitram (treprostinil extended-release) demonstrating improved hemodynamic parameters and risk status in patients with pulmonary arterial hypertension.
The FDA has granted Breakthrough Therapy designation to sotatercept (Acceleron Pharma) for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization Group 1).
Remunity is indicated for continuous subcutaneous delivery of Remodulin to treat pulmonary arterial hypertension in patients ≥22 years of age.
Bellerophon Therapeutics announced positive topline data from the phase 2b study of INOpulse® (pulsed, inhaled nitric oxide) delivery system for the treatment of pulmonary hypertension associated with pulmonary fibrosis (PH-PF).
