Liquidia Corporation announced today that the expiration of United Therapeutics’ new clinical investigation exclusivity for the use of Tyvaso treprostinil to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD) on March 31, 2024, along with court rulings on March 28 and March 29, has cleared the way for the FDA to issue final approval of the Liquidia’s NDA for Yutrepia treprostinil DPI.
The agency tentatively approved Yutrepia for the treatment of pulmonary arterial hypertension (PAH) in November 2021 and accepted Liquidia’s sNDA to add the PH-ILD indication in September 2023. Tyvaso inhalation solution was approved for the treatment of (PAH) in 2009 and for PH-ILD in March 2021. Tyvaso DPI was approved for both PAH and PH-ILD in May 2022.
On March 28, Liquidia says, a US District Court judge set aside an injunction issued in August 2022 as part of United Therapeutics’ litigation alleging patent infringement by Yutrepia. According to Liquidia, United Therapeutics has indicated that it intends to appeal this ruling and is also attempting to get new injunctions against final approval of Yutrepia.
In the March 29 ruling, the judge in United Therapeutic’s suit against the FDA over the agency’s handling of the Yutrepia sNDA denied a motion for a temporary restraining order and preliminary injunction to stop the FDA from approving the sNDA and ruled that United Therapeutics cannot challenge the agency’s actions until the FDA issues a decision on the sNDA. Earlier this year, the agency indefinitely extended the PDUFA goal date for review of the sNDA.
Liquidia also reports that United Therapeutics has initiated a new patent infringement suit alleging infringement of US Patent No. 11,826,327 (“Treatment for interstitial lung disease”), which was issued in November 2023, and is seeking a preliminary injunction in that case to stop Liquidia from launching Yutrepia for the treatment of PH-ILD.
Liquidia CEO Roger Jeffs commented, “With the recent decision by Judge Andrews, the path is cleared for us to seek final approval for Yutrepia. We have submitted the judge’s order to the FDA and look forward to a decision from the FDA in the near future. Our commercial team is fully prepared to launch Yutrepia in both PAH and PH-ILD should the FDA grant final approval. Once launched, we are confident that Yutrepia’s convenient, low-effort delivery and wide dosing range will propel the therapy towards our goal of establishing Yutrepia as the prostacyclin of first choice.”
Read the Liquidia press release.
