FDA grants tentative approval of Yutrepia (treprostinil) inhalation powder for patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD)

Tentative approval indicates that Yutrepia has met all regulatory standards for quality, safety and efficacy required for approval in the United States but must await the expiration of regulatory exclusivity of Tyvaso DPI before final approval can be granted.

Dr. Roger Jeffs, Ph.D., Chief Executive Officer of Liquidia, said: “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 May 23, 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.”

The tentative 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. The FDA’s approval also confirms that the supporting information related to the manufacturing, testing and supply chain of Yutrepia meets regulatory standards for quality and safety in accordance with Good Manufacturing Practices (GMP).

Liquidia must wait until United Therapeutics exclusivity runs out on May 23, 2025 to score final approval.

Tyvasvo’s recently-granted three-year exclusivity covers chronic use of “essentially any” dry powder formulation of treprostinil in the approved formulations following a new dosage strength that was approved in May 2024.

See-"INSPIRE: Safety and tolerability of inhaled Yutrepia (treprostinil) in pulmonary arterial hypertension (PAH)": 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