The U.S. District Court for the District of Columbia has dismissed a legal challenge filed by United Therapeutics (UTHR) against Liquidia Corporation's New Drug Application (NDA) amendment for YUTREPIA™ (treprostinil) inhalation powder, removing a significant obstacle to the drug's final approval and commercial launch.
Judge Timothy J. Kelly dismissed the cross-claim without prejudice on May 2, 2025, determining that United Therapeutics' challenge was "unripe" and that the company "failed to plausibly allege that it has standing" to contest Liquidia's NDA amendment that added pulmonary hypertension associated with interstitial lung disease (PH-ILD) to YUTREPIA's proposed label.
The ruling allows the U.S. Food and Drug Administration (FDA) to proceed with potential final approval of YUTREPIA after United Therapeutics' blocking regulatory exclusivity for its Tyvaso dry powder formulation expires on May 23, 2025. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of May 24, 2025, for Liquidia's application.
Legal and Regulatory Context
United Therapeutics had filed the cross-claim specifically challenging Liquidia's amendment to include the PH-ILD indication in its NDA for YUTREPIA, which had already received tentative FDA approval. The court's dismissal represents a significant victory for Liquidia in the ongoing competitive battle between the two companies in the pulmonary hypertension treatment space.
Dr. Roger Jeffs, CEO of Liquidia, expressed satisfaction with the court's decision: "We are pleased with the court's decision to dismiss this cross-claim, specifically holding that UTHR failed to establish standing. We also continue to believe that the FDA was correct to accept, and subsequently tentatively approve, our amended NDA for YUTREPIA to include the PH-ILD indication."
While United Therapeutics maintains the right to appeal the ruling, the decision significantly strengthens Liquidia's position as it approaches its target launch date. Following the announcement, Liquidia's shares rose by as much as 17% in trading.
YUTREPIA's Therapeutic Potential
YUTREPIA is an investigational dry powder formulation of treprostinil, a prostacyclin analog that is already approved in other formulations for the treatment of pulmonary arterial hypertension (PAH). The dry powder inhalation format offers potential advantages in terms of convenience and administration compared to existing nebulized or infused prostacyclin therapies.
If approved for both PAH and PH-ILD indications, YUTREPIA would address significant unmet needs in these rare but serious cardiopulmonary conditions. PAH is characterized by high blood pressure in the arteries of the lungs, while PH-ILD involves pulmonary hypertension specifically associated with interstitial lung diseases, which cause scarring of lung tissue.
Dr. Jeffs emphasized the company's focus on bringing the therapy to market: "We remain laser focused on the potential final approval of YUTREPIA following the expiration of gating regulatory exclusivity on May 23, 2025, and look forward to delivering what we believe will become the prostacyclin of first choice for patients with PAH and PH-ILD and the physicians who treat them."
Broader Portfolio and Company Strategy
Liquidia Corporation is developing YUTREPIA as part of a broader portfolio focused on rare cardiopulmonary diseases. The company leverages its proprietary PRINT® Technology platform to develop innovative therapies with potentially improved delivery mechanisms.
Beyond YUTREPIA, Liquidia is also developing L606, an investigational sustained-release formulation of treprostinil administered twice-daily with a next-generation nebulizer. Additionally, the company currently markets generic Treprostinil Injection for PAH treatment.
The court's decision represents a critical milestone in Liquidia's commercialization strategy as it positions itself to compete directly with United Therapeutics in the pulmonary hypertension market. Industry analysts will be closely watching the final FDA decision expected later this month and the subsequent commercial launch plans.
Market Implications
The pulmonary hypertension treatment market represents a significant commercial opportunity, with United Therapeutics' Tyvaso being a blockbuster therapy in this space. Liquidia's entry with YUTREPIA could potentially disrupt the current market dynamics by offering an alternative delivery mechanism for treprostinil.
The dismissal of United Therapeutics' challenge removes a significant uncertainty for Liquidia as it prepares for potential commercialization. The company will now focus on finalizing its launch preparations, including manufacturing, distribution, and market access strategies to ensure rapid availability of YUTREPIA following potential FDA approval.
With the legal hurdle cleared, attention now shifts to the FDA's final decision expected around May 24, 2025, which will determine whether YUTREPIA can enter the market as planned to serve patients with these serious cardiopulmonary conditions.
