Biopharmaceutical company Liquidia has received tentative approval from the US Food and Drug Administration (FDA) for YUTREPIA (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH).
The treatment is designed for adults with PAH and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
YUTREPIA is a dry-powder formulation of treprostinil, which patients can inhale through a palm-sized device.
It utilises Liquidia’s PRINT technology to create drug particles with precise size, shape and composition for optimal lung deposition after oral inhalation.
The Phase III INSPIRE trial, which included treprostinil-naïve patients and those transitioning from nebulised treprostinil, served as the basis for the tentative approval.
YUTREPIA demonstrated safety and tolerability across different patient exposures to treprostinil, with study results published in the Pulmonary Circulation Journal and the Vascular Pharmacology Journal.
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The FDA’s tentative approval also confirms that YUTREPIA’s manufacturing, testing, and supply chain information aligns with regulatory quality and safety standards under Good Manufacturing Practices (GMP).
Liquidia aims to secure final approval for YUTREPIA as soon as possible.
YUTREPIA is being evaluated in the ASCENT trial to determine its dosing and tolerability profile in PH-ILD patients.
During earlier investigational studies, the therapy was known as LIQ861.
In February 2024, United Therapeutics sued the FDA, claiming that the agency did not follow rules when approving a change to rival Liquidia’s new drug application (NDA).
Liquidia CEO Dr Roger Jeffs stated: “We are pleased that the FDA agreed that our NDA amendment last July was proper, providing a clear path to full approval of YUTREPIA in both PAH and PH-ILD.
“However, we are disappointed and disagree with the FDA’s decision to simultaneously grant regulatory exclusivity to United Therapeutics for Tyvaso DPI that encompasses chronic use of essentially any dry-powder formulation of treprostinil in the approved indications for a three-year period for its new dosage form approved on 23 May 2022.
“We plan to take quick action to challenge the FDA’s broad grant of regulatory exclusivity and defend the ability for patients to have access to YUTREPIA with the least delay possible.”
