District Court Dismisses Dispute Filed by United Therapeutics Against Liquidia
The U.S. District Court for the District of Columbia has dismissed United Therapeutics' (UTHR) cross-claim challenging Liquidia's (LQDA) amended New Drug Application for YUTREPIA™. The court ruled that UTHR's claim was unripe and lacked standing. The amended NDA seeks to add the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) to YUTREPIA's label.
The FDA has already granted tentative approval for YUTREPIA and set a PDUFA goal date of May 24, 2025. Final approval can be granted after the blocking regulatory exclusivity expires on May 23, 2025. While UTHR maintains the right to appeal, Liquidia's CEO expressed confidence in the FDA's decision to accept and tentatively approve the amended NDA.
Il Tribunale Distrettuale degli Stati Uniti per il Distretto di Columbia ha respinto la contro-domanda di United Therapeutics (UTHR) che contestava la domanda di nuovo farmaco modificata di Liquidia (LQDA) per YUTREPIA™. Il tribunale ha stabilito che la richiesta di UTHR non era matura e mancava di legittimazione. La domanda modificata mira ad aggiungere al foglietto illustrativo di YUTREPIA il trattamento dell'ipertensione polmonare associata a malattia polmonare interstiziale (PH-ILD).
La FDA ha già concesso un'approvazione provvisoria per YUTREPIA e ha fissato una data obiettivo PDUFA per il 24 maggio 2025. L'approvazione definitiva potrà essere concessa dopo la scadenza dell'esclusiva regolatoria, prevista per il 23 maggio 2025. Sebbene UTHR mantenga il diritto di presentare ricorso, l'amministratore delegato di Liquidia ha espresso fiducia nella decisione della FDA di accettare e concedere l'approvazione provvisoria alla domanda modificata.
El Tribunal de Distrito de los Estados Unidos para el Distrito de Columbia ha desestimado la contrademanda de United Therapeutics (UTHR) que impugnaba la solicitud modificada de Nuevo Medicamento de Liquidia (LQDA) para YUTREPIA™. El tribunal dictaminó que la reclamación de UTHR no estaba madura y carecía de legitimación. La NDA modificada busca añadir al etiquetado de YUTREPIA el tratamiento de la hipertensión pulmonar asociada con enfermedad pulmonar intersticial (PH-ILD).
La FDA ya ha otorgado una aprobación tentativa para YUTREPIA y estableció una fecha objetivo PDUFA para el 24 de mayo de 2025. La aprobación final puede concederse después de que expire la exclusividad regulatoria bloqueante el 23 de mayo de 2025. Aunque UTHR mantiene el derecho a apelar, el CEO de Liquidia expresó confianza en la decisión de la FDA de aceptar y aprobar tentativamente la NDA modificada.
미국 컬럼비아 지구 연방지방법원은 Liquidia(LQDA)의 수정된 신약 신청서인 YUTREPIA™에 대해 United Therapeutics(UTHR)의 반소 청구를 기각했습니다. 법원은 UTHR의 청구가 시기상조이며 법적 자격이 없다고 판결했습니다. 수정된 NDA는 YUTREPIA의 라벨에 간질성 폐질환 관련 폐고혈압(PH-ILD) 치료를 추가하려는 것입니다.
FDA는 이미 YUTREPIA에 대해 잠정 승인을 부여했으며 2025년 5월 24일 PDUFA 목표일을 설정했습니다. 최종 승인은 2025년 5월 23일 차단 규제 독점권이 만료된 후에 부여될 수 있습니다. UTHR가 항소할 권리는 유지되지만, Liquidia의 CEO는 FDA가 수정된 NDA를 수락하고 잠정 승인한 결정에 자신감을 표명했습니다.
Le tribunal de district des États-Unis pour le district de Columbia a rejeté la demande reconventionnelle de United Therapeutics (UTHR) contestant la demande modifiée de nouveau médicament de Liquidia (LQDA) pour YUTREPIA™. Le tribunal a jugé que la demande de UTHR n'était pas mûre et manquait de qualité pour agir. La NDA modifiée vise à ajouter le traitement de l'hypertension pulmonaire associée à la maladie pulmonaire interstitielle (PH-ILD) à l'étiquette de YUTREPIA.
La FDA a déjà accordé une approbation provisoire pour YUTREPIA et fixé une date cible PDUFA au 24 mai 2025. L'approbation finale pourra être accordée après l'expiration de l'exclusivité réglementaire bloquante le 23 mai 2025. Bien que UTHR conserve le droit de faire appel, le PDG de Liquidia a exprimé sa confiance dans la décision de la FDA d'accepter et d'approuver provisoirement la NDA modifiée.
Das US-Bezirksgericht für den District of Columbia hat die Gegenklage von United Therapeutics (UTHR) abgewiesen, die die geänderte Zulassungsanfrage von Liquidia (LQDA) für YUTREPIA™ anfocht. Das Gericht entschied, dass die Klage von UTHR noch nicht reif war und keine Klagebefugnis bestand. Die geänderte NDA zielt darauf ab, die Behandlung der pulmonalen Hypertonie im Zusammenhang mit interstitieller Lungenerkrankung (PH-ILD) in das Etikett von YUTREPIA aufzunehmen.
Die FDA hat bereits eine vorläufige Zulassung für YUTREPIA erteilt und ein PDUFA-Zieldatum am 24. Mai 2025 festgelegt. Die endgültige Zulassung kann nach Ablauf der blockierenden regulatorischen Exklusivität am 23. Mai 2025 erteilt werden. Während UTHR das Recht hat, Berufung einzulegen, zeigte sich der CEO von Liquidia zuversichtlich bezüglich der Entscheidung der FDA, die geänderte NDA anzunehmen und vorläufig zu genehmigen.
- Court dismissed UTHR's challenge to YUTREPIA's PH-ILD indication, strengthening Liquidia's position
- FDA can grant final approval for YUTREPIA after May 23, 2025, opening path to commercialization
- YUTREPIA has potential to become first-choice treatment for both PAH and PH-ILD indications
- UTHR maintains the right to appeal the court's decision, which could lead to further legal challenges
- Final approval still pending and subject to regulatory review
- Company must wait until May 23, 2025 for regulatory exclusivity expiration before potential approval
Insights
Court dismissal removes legal obstacle for Liquidia's YUTREPIA approval pathway, preserving their May 24th PDUFA date.
The U.S. District Court's dismissal of United Therapeutics' cross-claim against Liquidia represents a significant procedural victory in Liquidia's regulatory journey. Judge Kelly dismissed the claim without prejudice, finding it unripe and that UTHR failed to establish standing - two fundamental jurisdictional requirements in federal litigation.
This ruling effectively protects Liquidia's amended NDA for YUTREPIA, which added the PH-ILD (pulmonary hypertension associated with interstitial lung disease) indication to the original PAH indication. The dismissal for lack of standing is particularly noteworthy, as standing challenges attack a plaintiff's fundamental right to bring a claim.
While the "without prejudice" designation technically allows UTHR to refile their claim if circumstances change, overcoming the standing deficiency presents a significant hurdle. The press release does note that UTHR retains the right to appeal this ruling to a higher court.
This decision keeps Liquidia on track for its established regulatory timeline, maintaining the path to potential final approval after the expiration of the blocking regulatory exclusivity on May 23, 2025, with the FDA's PDUFA date set for May 24, 2025. The court has effectively declined to interfere with the FDA's regulatory process regarding YUTREPIA's expanded indication.
Court dismissal preserves Liquidia's expanded indication for YUTREPIA, positioning it for potential approval immediately after exclusivity expires in May 2025.
This court decision represents a significant regulatory victory for Liquidia's YUTREPIA (treprostinil) inhalation powder. The FDA has already granted tentative approval for Liquidia's NDA including both the PAH and PH-ILD indications. In FDA terminology, tentative approval signals that an application meets all technical and safety requirements but cannot receive final approval due to existing patents or exclusivity periods.
The expanded label to include PH-ILD (pulmonary hypertension associated with interstitial lung disease) alongside PAH (pulmonary arterial hypertension) is strategically important for Liquidia. PH-ILD represents a distinct patient population, potentially broadening YUTREPIA's market reach and clinical utility.
The regulatory timeline is now clearly defined: the blocking regulatory exclusivity expires on May 23, 2025, and the FDA has set a PDUFA goal date of May 24, 2025 - just one day later. This sequential timing strongly suggests the FDA is prepared to act immediately once the exclusivity period ends.
This dismissal removes what could have been a significant complication in YUTREPIA's approval pathway. United Therapeutics' challenge specifically targeted the PH-ILD indication addition, which could have potentially forced Liquidia to launch with a more limited label had UTHR prevailed.
The CEO's statement that YUTREPIA will become "the prostacyclin of first choice" signals confidence in the product's competitive profile against existing prostacyclin therapies in this space, which includes products from United Therapeutics.
- Court will not hear cross-claim that challenges the PH-ILD indication in the tentatively approved NDA for YUTREPIA
- FDA can grant final approval of YUTREPIA after blocking regulatory exclusivity expires on May 23, 2025
MORRISVILLE, N.C., May 02, 2025 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease, today announced that Judge Kelly of the U.S. District Court for the District of Columbia (District Court) dismissed, without prejudice, the cross-claim filed by United Therapeutics (UTHR) that sought to challenge Liquidia’s amendment to its New Drug Application (NDA) for YUTREPIA™ (treprostinil) inhalation powder, which added the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) to the proposed label for YUTREPIA. In its ruling, the District Court determined that UTHR’s claim was unripe and that UTHR had failed to plausibly allege that it has standing.
Dr. Roger Jeffs, CEO, Liquidia said: “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. 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.”
UTHR has the right to appeal the Court’s ruling.
The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date for the YUTREPIA NDA of May 24, 2025.
About Liquidia Corporation
Liquidia Corporation is a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease. The company’s current focus spans the development and commercialization of products in pulmonary hypertension and other applications of its proprietary PRINT® Technology. PRINT enabled the creation of Liquidia’s lead candidate, YUTREPIA™ (treprostinil) inhalation powder, an investigational drug for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The company is also developing L606, an investigational sustained-release formulation of treprostinil administered twice-daily with a next-generation nebulizer, and currently markets generic Treprostinil Injection for the treatment of PAH. To learn more about Liquidia, please visit www.liquidia.com.
Cautionary Statements Regarding Forward-Looking Statements
This press release may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical facts, including statements regarding our future results of operations and financial position, our strategic and financial initiatives, our business strategy and plans and our objectives for future operations, are forward-looking statements. Such forward-looking statements, including statements regarding clinical trials, clinical studies and other clinical work (including the funding therefor, anticipated patient enrollment, safety data, study data, trial outcomes, timing or associated costs), regulatory applications and related submission contents and timelines, including the potential for final FDA approval of the NDA for YUTREPIA, the timeline or outcome of the cross-claims that United Therapeutics has brought against the FDA, the timeline or outcome related to patent litigation in the U.S. District Court for the District of Delaware, including rehearings or appeals of decisions in any such proceedings, the issuance of patents by the USPTO and our ability to execute on our strategic or financial initiatives, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. The decisions of courts or other tribunals are not determinative of the outcome of the appeals or rehearings of the decisions. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives and financial needs. These forward-looking statements are subject to a number of risks discussed in our filings with the SEC, as well as a number of uncertainties and assumptions. Moreover, we operate in a very competitive and rapidly changing environment and our industry has inherent risks. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the future events discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Nothing in this press release should be regarded as a representation by any person that these goals will be achieved, and we undertake no duty to update our goals or to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact Information
Investors:
Jason Adair
Chief Business Officer
919.328.4350
jason.adair@liquidia.com
Media:
Patrick Wallace
Director, Corporate Communications
919.328.4383
patrick.wallace@liquidia.com
FAQ
What was the court's decision on United Therapeutics' claim against Liquidia's YUTREPIA?
When is the PDUFA date for Liquidia's (LQDA) YUTREPIA?
What indications is Liquidia (LQDA) seeking for YUTREPIA?
Why can't the FDA grant final approval for YUTREPIA immediately?
Can United Therapeutics challenge the court's decision on YUTREPIA?
