Liquidia Corporation Provides Update on New Drug Application for YUTREPIA™ (treprostinil) inhalation powder
Liquidia Corporation announces FDA update on YUTREPIA NDA for treating pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. The FDA is confirming the process for adding the PH-ILD indication as an amendment to the NDA for YUTREPIA, causing a delay in the action letter issuance. The FDA did not request additional clinical data and did not issue a new PDUFA goal date. The company remains committed to preparing for the final FDA approval of YUTREPIA. Litigation filed by United Therapeutics alleging patent infringement of U.S. Patent No. 10,716,793 and U.S. Patent No. 11,826,327 is ongoing.
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The delay in the action letter issuance due to the confirmation process for adding the PH-ILD indication may result in a delay in the final FDA approval of YUTREPIA, potentially affecting the company's revenue and stock performance.
The update on the FDA's review process for Liquidia Corporation's YUTREPIA™ is significant for stakeholders, as it pertains to the drug's market authorization for an additional indication, PH-ILD. The FDA's decision to consider the amendment without requiring new clinical data suggests confidence in the existing evidence base. However, the absence of a new PDUFA goal date introduces uncertainty into the approval timeline. This could affect the company's stock as investors typically seek clarity on regulatory milestones. The ongoing litigation adds another layer of complexity, potentially influencing market exclusivity and the ability to capitalize on the new indication without legal impediments.
The affirmation by the CAFC that the ‘793 Patent is unpatentable due to prior art is a pivotal development for Liquidia. It potentially clears a significant legal hurdle that could have otherwise delayed or prevented the commercialization of YUTREPIA™. The stipulation to dismiss the '793 Patent from the ongoing litigation is a strategic win for Liquidia, as it reduces the scope of the legal battle to the '327 Patent. However, the assertion that the '327 Patent, which was not issued at the time of the NDA submission, should not incur a statutory 30-month stay is subject to legal interpretation and could be contested, keeping investors watchful of the litigation's outcome.
The potential expansion of YUTREPIA™'s label to include PH-ILD could open up a new market segment for Liquidia Corporation, addressing unmet needs in the treatment of pulmonary hypertension. The previous tentative approval for PAH and the FDA's indication that no additional clinical data is required for the PH-ILD indication suggest that YUTREPIA™ has a strong safety and efficacy profile. The market response will likely be influenced by the resolution of regulatory and legal challenges. A successful launch could position Liquidia as a notable player in the PAH and PH-ILD treatment landscape, which would be reflected in investor sentiment and stock valuation.
01/25/2024 - 06:00 AM
MORRISVILLE, N.C., Jan. 25, 2024 (GLOBE NEWSWIRE) -- Liquidia Corporation (the Company) (NASDAQ: LQDA) announced today that the U.S. Food and Drug Administration (FDA) provided an update on its review of the New Drug Application (NDA) for YUTREPIA™ (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The FDA informed the Company that it is confirming the process for adding the PH-ILD indication as an amendment to the NDA for YUTREPIA. Accordingly, the FDA is not able to issue an action letter in time to meet the previously issued Prescription Drug User Fee Act (PDUFA) goal date of January 24, 2024, and their review remains ongoing. The FDA did not request any additional clinical data to support the NDA and did not issue a new PDUFA goal date.
Dr. Roger Jeffs, Chief Executive Officer, said: “We are in active communication with the FDA regarding the process we followed to amend our NDA to add PH-ILD to the labeled indication. Whether the NDA is amended or supplemented, we will continue to prepare for the final FDA approval of YUTREPIA to treat both PAH and PH-ILD patients following the expiration of regulatory exclusivity for Tyvaso® on March 31, 2024. As communicated by the tentative approval to treat PAH, YUTREPIA has already met the regulatory standards for quality, safety and efficacy. We remain committed to addressing the unmet needs across all patients whose lives may be improved by the unique benefits of YUTREPIA.”
On November 5, 2021, the FDA issued a tentative approval for YUTREPIA for the treatment of PAH to improve exercise ability in adult patients with New York Heart Association (NYHA) Functional Class II-III symptoms. In July 2023, Liquidia filed an amendment to its New Drug Application for YUTREPIA, seeking to add PH-ILD to the label. The FDA previously confirmed that YUTREPIA may include the treatment of PH-ILD to the proposed label for YUTREPIA without additional clinical studies.
YUTREPIA also remains subject to ongoing litigation. Liquidia filed a request for Judge Andrews of the U.S. District Court for the District of Delaware (District Court) to set aside the injunction that was instituted in August 2022 tied to litigation filed by United Therapeutics (UTHR) alleging patent infringement of U.S. Patent No. 10,716,793 (the ‘793 Patent) in Case No. 1:20-cv-00755-RGA (the Original Hatch-Waxman Litigation). On December 20, 2023, the United States Court of Appeals for the Federal Circuit (CAFC) affirmed the earlier decision by the Patent Trial and Appeal Board (PTAB), which found all claims of the ‘793 Patent to be unpatentable due to the existence of prior art cited by Liquidia in inter partes review proceedings.
Additionally, in September 2023, UTHR filed a second complaint for patent infringement in District Court in Case No. 1:23-cv-00975-RGA (the New Hatch-Waxman Litigation). As of January 22, 2024, the only patent at issue is U.S. Patent No. 11,826,327 (the ‘327 Patent) which issued November 30, 2023. UTHR has stipulated to the dismissal of the ‘793 Patent from the New Hatch-Waxman Litigation as a result of the CAFC decision affirming invalidity of the '793 Patent. The ’327 Patent, the sole remaining patent at issue in the New Hatch-Waxman Litigation, was not issued before Liquidia submitted the NDA for YUTREPIA in January 2020 to treat PAH. Therefore, the Company believes that final FDA approval for YUTREPIA will not be subject to any statutory 30-month stay arising from the New Hatch-Waxman Litigation per Section 505(c)(3)(C) of the Federal Food, Drug and Cosmetic Act.
About YUTREPIA™(treprostinil) inhalation powder
YUTREPIA is an investigational, inhaled dry powder formulation of treprostinil delivered through a convenient, low-resistance, palm-sized device. YUTREPIA was designed using Liquidia’s PRINT® technology, which enables the development of drug particles that are precise and uniform in size, shape, and composition, and that are engineered for enhanced deposition in the lung following oral inhalation. Liquidia has completed INSPIRE, or Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil, an open-label, multi-center phase 3 clinical study of YUTREPIA in patients diagnosed with PAH who are naïve to inhaled treprostinil or who are transitioning from Tyvaso® (nebulized treprostinil). YUTREPIA is currently being studied in the ASCENT trial, an Open-Label Prospective Multicenter Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in Pulmonary Hypertension, with the objective of informing YUTREPIA’s dosing and tolerability profile in patients with PH-ILD. YUTREPIA was previously referred to as LIQ861 in investigational studies.
About Liquidia Corporation
Liquidia Corporation is a biopharmaceutical company focused on the development and commercialization of products in pulmonary hypertension and other applications of its PRINT® Technology. The Company operates through its two wholly owned subsidiaries, Liquidia Technologies, Inc. (Liquidia Technologies) and Liquidia PAH, LLC (Liquidia PAH). Liquidia Technologies has developed YUTREPIA™ (treprostinil) inhalation powder for the treatment of PAH and PH-ILD. Liquidia Technologies is also developing L606, an investigational liposomal formulation of treprostinil administered twice-daily with a short-duration next-generation nebulizer, for use in North America. Liquidia PAH provides for the commercialization of pharmaceutical products to treat pulmonary disease, such as generic Treprostinil Injection. For more information, please visit www.liquidia.com .
Tyvaso® is a registered trademark of United Therapeutics Corporation.
Cautionary Statements Regarding Forward-Looking Statements inter partes review proceedings conducted at the PTAB, including appeals of decisions in any such proceedings, the timeline associated with any regulatory stay provisions, 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 favorable decisions of lower tribunals are not determinative of the outcome of the appeals 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
Media & Investors: jason.adair@liquidia.com
The FDA is confirming the process for adding the PH-ILD indication as an amendment to the NDA for YUTREPIA, which has caused a delay in the action letter issuance.
The FDA's update has resulted in a delay in the action letter issuance, causing the PDUFA goal date to be missed.
No, the FDA did not request any additional clinical data to support the NDA for YUTREPIA.
The final FDA approval of YUTREPIA is being prepared for, despite the delay in the action letter issuance due to the confirmation process for adding the PH-ILD indication as an amendment to the NDA.
United Therapeutics has filed litigation alleging patent infringement of U.S. Patent No. 10,716,793 and U.S. Patent No. 11,826,327, which is currently ongoing.
