FDA approves inhaled therapy

Liquidia Corporation announced that the FDA has approved Yutrepia (treprostinil) inhalation powder, a prostacyclin analog for adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise ability. Yutrepia is the first and only prostacyclin dry-powder formulation enabled by Liquidia’s proprietary PRINT technology, which yields uniform, free-flowing particles designed to enhance deep-lung delivery via an easy-to-use, low-effort device requiring less inspiratory effort.

The approval of Yutrepia is based on findings from the Phase III INSPIRE trial which evaluated patients who were naïve to treprostinil, as well as those transitioning to Yutrepia from nebulized treprostinil. Yutrepia was shown to be safe and well-tolerated regardless of a patient’s previous exposure to treprostinil. Results from the INSPIRE study were published in the Pulmonary Circulation Journal in 2022 and the Vascular Pharmacology Journal in 2021. 

Dr. Roger Jeffs, Chief Executive Officer of Liquidia, said: “Today, 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. Thank you to the clinical investigation team, our steering committee, and the members of the pulmonary hypertension patient communities who helped make this day a reality. With today’s milestone, our commercial team is prepared to launch Yutrepia and bring meaningful change to the lives of patients in need, and we look forward to speaking with physicians and patients about the unique benefits of Yutrepia in the days and weeks ahead.”

Dr. Nicholas Hill, Chief Pulmonary, Critical Care & Sleep Division, Professor of Medicine at Tufts University School of Medicine and Principal Investigator on the Phase III INSPIRE study, said: “I am so pleased that patients with PAH and PH-ILD now have this newly introduced option for inhaled treprostinil. Having treated patients for more than six years in Liquidia’s INSPIRE and extension studies, I am confident in the safety, tolerability and dosing that Yutrepia offers. 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.”

Matt Granato, President and Chief Executive Officer of the Pulmonary Hypertension Association, said: “PAH and PH-ILD impact more than 105,000 patients in the U.S. alone. These patient communities and the physicians who serve them need therapies that can lead to the improvement of quality of life. We are always glad to see industry research leading to development of drugs that expand options for the patient community.” 

Citation: INSPIRE: Safety and tolerability of inhaled Yutrepia (treprostinil) in pulmonary arterial hypertension (PAH). Authors: Nicholas S. Hill, , Jeremy P. Feldman, Sandeep Sahay, Raymond L. Benza, et al. the INSPIRE study investigators Pulmonary Circulation Volume 12, Issue 3, First published: 26 July 2022

Comparative bioavailability of inhaled treprostinil administered as LIQ861 and Tyvaso in healthy subjects. Authors: Robert F. Roscigno , Toby Vaughn , Ed Parsley et al. Vascular Pharmacology Volume 138, June 2021, 106840