According to Liquidia Corporation, a judge in the US District Court for the District of Delaware has denied a United Therapeutics motion seeking a preliminary injunction to prevent Liquidia from launching Yutrepia treprostinil DPI for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). Earlier this year, the company said that recent rulings in the case had cleared the way for final approval of its NDA for Yutrepia for PH-ILD.
The FDA granted tentative approval for Liquidia’s NDA for Yutrepia for the treatment of pulmonary arterial hypertension (PAH) in November 2021 and accepted the sNDA to add the PH-ILD indication in September 2023. United Therapeutics filed suit shortly after the sNDA was filed, alleging patent infringement, and the trial is expected to begin in June 2025, Liquidia says.
Although the FDA had set a PDUFA goal date of January 24, 2004 for completion of the review of the sNDA, Liquidia announced shortly after that date that the agency was delaying its decision and said that it needed to determine the correct process for approving the addition of the PH-ILD indication. The next month, United Therapeutics sued the FDA alleging that the agency’s handling of the sNDA was improper.
Liquidia CEO Roger Jeffs commented, “We are pleased that Judge Andrews ruled that United Therapeutics’ request for an injunction failed on critical grounds, including UTHR’s failure to show our obviousness challenge lacks substantial merit and UTHR’s failure to show that the public interest weighs in favor of an injunction. While we await a final FDA action, we will continue to intensify our commercial preparations as we work to make this important treatment option available to pulmonary arterial hypertension and PH-ILD patients.”
Read the Liquidia Corporation press release.
