The U.S. Food and Drug Administration (FDA) has granted approval of Yutrepia (treprostinil) inhalation powder for adults who have pulmonary arterial hypertension (PAH) or pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise ability.
According to its manufacturer, biopharmaceutical company Liquidia, Yutrepia produces “uniform, free-flowing particles designed to enhance deep-lung delivery via an easy-to-use, low-effort device.”
Liquidia CEO Roger Jeffs, PhD, said: “We celebrate for the patients and physicians who will now have access to a potential best-in-class, dry-powder form of treprostinil with exceptional portability, tolerability, titratability and durability.”
Approval of Yutrepia (a prostacyclin analog) was based on results of the phase 3 INSPIRE clinical trial, which evaluated patients who were new treprostinil users or were switching from nebulized treprostinil to inhaled treprostinil. Regardless of a patient’s prior exposure to the drug, Yutrepia demonstrated safety and tolerability. Complete findings from INSPIRE were published in the journals Pulmonary Circulation and Vascular Pharmacology.
“The low-effort inhalation device used to deliver Yutrepia may make it easier to start and maintain patients on treatment, especially those with limited inspiratory flows or lung capacity,” said principal investigator Nicholas Hill, MD, chief, pulmonary, critical care and sleep division, and professor at Tufts University School of Medicine.
In its press release, Liquidia also disclosed a pending motion filed by United Therapeutics Corporation (UTHR) in the U.S. District Court for the Middle District of North Carolina regarding patent infringement.
