Liquidia Challenges FDA Exclusivity on YUTREPIA™ (treprostinil)
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Liquidia Challenges Regulatory Exclusivity Affecting YUTREPIA™ Approval
Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company dedicated to innovative therapies for patients suffering from rare cardiopulmonary diseases, has recently filed litigation in the U.S. District Court of the District of Columbia seeking to contest a decision made by the United States Food and Drug Administration (FDA). This decision granted three-year new clinical investigation exclusivity (NCI exclusivity) to Tyvaso DPI, significantly delaying the approval of Liquidia's own YUTREPIA™ (treprostinil) inhalation powder.
Background on the Licensing and Approval Process
The FDA granted tentative approval for YUTREPIA™, an inhalation powder that addresses pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). However, with the FDA's recent decision to extend NCI exclusivity to Tyvaso DPI, YUTREPIA’s final approval has now been postponed until after the exclusivity period ends on May 23, 2025. This situation not only hinders market access but also impacts patient care and their treatment options.
CEO's Statement on Regulatory Decision
Dr. Roger Jeffs, Ph.D., Chief Executive Officer of Liquidia, expressed strong discontent regarding the FDA's recent action. He stated that the decision improperly benefits United Therapeutics by allowing them to impose additional regulatory exclusivity, thus limiting competition and patient choice. He emphasized that the intent of Congress was to ensure NCI exclusivity is only given for genuine innovations backed by substantial clinical studies. Liquidia firmly believes that the FDA's move to extend exclusivity to Tyvaso DPI should be overturned, enabling YUTREPIA to enter the market promptly for patient benefit.
Understanding Pulmonary Arterial Hypertension and Its Impact
Pulmonary arterial hypertension (PAH) is a rare and progressive disorder characterized by the narrowing and hardening of the pulmonary arteries, which can lead to right heart failure and potentially fatal outcomes. In the United States alone, around 45,000 patients are diagnosed with PAH, and currently, there are no cures available. Existing treatment protocols focus on alleviating symptoms, delaying disease progression, and improving the quality of life for patients.
Interstitial Lung Disease and Its Relation to Pulmonary Hypertension
Pulmonary hypertension associated with interstitial lung disease (PH-ILD) encompasses a variety of pulmonary conditions, with up to 150 different diseases included. The presence of PH in ILD patients is correlated with unfavorable survival rates. The estimated prevalence of PH-ILD in the United States exceeds 60,000, though many underlying conditions may be underdiagnosed, complicating accurate assessments of the patient population.
About YUTREPIA™ (treprostinil) Inhalation Powder
YUTREPIA is an inhaled dry-powder formulation of treprostinil, designed for ease of use with a compact device. This product was developed utilizing Liquidia’s PRINT technology, which creates precise and uniform particles aimed at optimized delivery within the lungs during inhalation.
Clinical Studies and Ongoing Research
Liquidia has successfully completed the INSPIRE study, which investigated the safety and pharmacology of this innovative treatment in patients new to inhaled treprostinil or transitioning from Tyvaso. Currently, YUTREPIA is being evaluated in an open-label multicenter study called ASCENT, intended to determine the safety and tolerability profile for patients experiencing PH-ILD. Previously, YUTREPIA was known as LIQ861 during its investigational phase.
Liquidia Corporation: Driving Innovation in Pulmonary Therapeutics
Liquidia Corporation is focused on developing groundbreaking therapies for individuals suffering from rare cardiopulmonary diseases. The company's mission is centered around creating innovative solutions to address unmet medical needs in the realm of pulmonary hypertension, alongside leveraging its proprietary PRINT technology for broader applications. Alongside YUTREPIA™, Liquidia is advancing multiple products to enhance patient care, including an investigational sustainable-release formulation of treprostinil and currently marketed generic Treprostinil Injection for PAH treatment.
Frequently Asked Questions
What is YUTREPIA™ used for?
YUTREPIA™ is an inhalation powder formulated to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
Why has the approval of YUTREPIA™ been delayed?
The FDA has granted NCI exclusivity to Tyvaso DPI, which delays the approval process for YUTREPIA™ until after this exclusivity period ends.
What is NCI exclusivity?
NCI exclusivity is a regulatory status awarded by the FDA to incentivize drug innovation, allowing a period of exclusivity for new clinical studies demonstrating safety and efficacy.
How does Liquidia plan to address the delay in YUTREPIA™ approval?
Liquidia has initiated legal action to challenge the decision granting exclusivity to Tyvaso DPI and aims to expedite the approval of YUTREPIA™ for patient access.
Who can I contact for more information about Liquidia Corporation?
For investor inquiries, contact Jason Adair at 919.328.4350, or for media inquiries, contact Patrick Wallace at 919.328.4383.
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