FDA extends tentative Yutrepia approval to PH-ILD
Liquidia must wait for final OK until Tyvaso's marketing rights expire
The U.S. Food and Drug Administration (FDA) has extended its tentative approval of Yutrepia, an inhaled dry powder formulation of treprostinil, to pulmonary hypertension associated with interstitial lung disease (PH-ILD), a condition that causes the lungs to become scarred.
Liquidia’s Yutrepia was granted tentative approval in 2021 to improve the ability to exercise in adults with pulmonary arterial hypertension (PAH), but a full approval, which allows commercial use, was delayed due to patent infringement claims against the company.
Tentative approval means Yutrepia meets all regulatory standards for quality, safety, and efficacy in the U.S., but must wait until the exclusive marketing rights for United Therapeutics’ Tyvaso DPI expire before it can get final approval.
Tyvaso DPI remains the only inhaled dry powder treprostinil formulation approved in the U.S. to improve the ability to exercise in adults with PAH or PH-ILD, and it holds a three-year exclusivity period that protects it from market competition until May 23, 2025.
A step forward for Yutrepia
Liquidia sought the extension to PH-ILD in the form of an amended new drug application (NDA) after the FDA confirmed no more clinical studies would be needed to support a decision. Despite the setbacks, Liquidia plans to seek final approval as early as possible.
“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,” Roger Jeffs, PhD, Liquidia’s CEO, said in a company press release. “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.”
Yutrepia is a compound that acts similarly to prostacyclin, a vasodilator that widens and relaxes blood vessels, reducing blood pressure. Delivered via a palm-sized device, it’s inhaled directly into the lungs.
Its tentative approval was based on data from INSPIRE (NCT03399604), a Phase 3 clinical study that showed the medication was safe and well tolerated, and improved exercise capacity and quality of life in adults with PAH who’d never taken inhaled treprostinil or had switched from Tyvaso, which is nebulized treprostinil.
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