US-based biopharmaceutical company Liquidia has received the US Food and Drug Administration (FDA) tentative approval for Yutrepia (treprostinil) to treat patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD)
Yutrepia is an inhaled dry-powder formulation of Treprostinil, delivered through a convenient, low-effort, palm-sized device, for enhanced deposition in the lung.
The drug is engineered using the company’s PRINT technology, which enables the development of drug particles that are precise and uniform in size, shape, and composition.
The tentative approval means Yutrepia has met all regulatory requirements but can be granted final approval only after the expiration of the regulatory exclusivity of a competing product.
Liquidia CEO Roger Jeffs said: “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.
“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 approved on 23 May 2022.
“We plan to take quick action to challenge the FDA’s broad grant of regulatory exclusivity and defend the ability for patients to have access to Yutrepia with the least delay possible.”
The tentative approval of Yutrepia is based on results from the Phase 3 INSPIRE clinical trial in patients who were naïve to treprostinil, and those moving to Yutrepia from nebulized treprostinil.
In the Phase 3 clinical study, the inhalation powder treatment was shown to be safe and well-tolerated regardless of a patient’s previous exposure to treprostinil.
The FDA approval also confirms that the supporting information related to the manufacturing, testing and supply chain of the drug meets Good Manufacturing Practices (GMP) standards.
Yutrepia, previously referred to as LIQ861, is currently being studied in the ASCENT trial to evaluate the safety and tolerability of dry powder inhaled treprostinil in pulmonary hypertension.
Furthermore, Liquidia said it will continue to address the unmet needs of PAH and PH-ILD patients and seek the FDA’s final approval for Yutrepia as early as possible.
