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Courts clear hurdles for Liquidia's Yutrepia, potentially allowing for new rival to United's PAH franchise
2024-04-02
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After two federal court decisions last week, Liquidia Corporation says that the FDA is cleared to approve its pulmonary arterial hypertension inhaler Yutrepia, a potential rival to United Therapeutics' blockbuster Tyvaso.
With one injunction lifted and another deniedLiquidia Corporationawsuits filed bFDAnited Therapeutics, rival Lpulmonary arterial hypertensionA has cleYutrepiao approve its pulmonaryUnited Therapeuticsion (PAH) treaTyvasoYutrepia.
Thursday in U.S. District Court in Delaware, in United’s original patent case agaiUnited Therapeutics RichardLiquidia CorporationinjunctionFDAat had prohibited the FDA frompulmonary arterial hypertension (PAH)led the decYutrepia
A day later,U.S. District Courtn Washington, D.C., Judge John Bates denied a motion for a temporary restraining order in litigation filed by United against the FDA.FDA
The decisions came shortly before the expiration on Sunday of United’s regulatory exclusivity for its PAH blockbuster Tyvaso (treprostinil) to treat pulmonary hFDArtension associated with interstitial lung disease (PH-ILD). The developments could spell the end of the short reign of exclusivity for United’s successful dry powder inhaler (DPI) formulation of the drug.
The new version of Tyvaso was approved in May of 2022 and accounted for 59% ($731 million) of the franPAHse's sales ofTyvaso btreprostinilyear. Tyvaspulmonary hypertensiono a company recorinterstitial lung disease (PH-ILD)023, a 20% increase from 2022.
The FDA accepted LiTyvaso’s application for a dry powder version of treprostinil in 2020 and then rejected it with a complete response letter seven months later. A year later, the FDA granted tentative approval to Yutrepia.
LastFDAar, the FDLiquidiaed Liquidia’s amendment to the filing whichtreprostiniladdition of a second indication, pulmonary hypertension associated with interstitial lung disease (PFDALD).Yutrepia
That prompted UFDAed to sue the FDA, claiming that the regulator allowed Liquidia to sidestep “rules, precedents pulmonary hypertensionepting the amendminterstitial lung disease (PH-ILD) should have required Liquidia to submit an entirely separate application to treat PH-ILD.
“Our commercial team is fully prFDAred to launch Yutrepia in both PAH andLiquidiashould the FDA grant final approval," Roger Jeffs, CEO of Liquidia, said in a release. "Once launched,FDA are confident that YuLiquidia convenient, low-effort delivery and wide dosing rangPH-ILD propel the therapy towards our goal of establishing Yutrepia as the prostacyclin of first choice.”
The company has filed an additional lawsuit against Liquidia in federal court in Delaware alleging that Yutrepia would infringe a patent that was issued in November of last year. United has filed for another preliminary injunction in that case which would prevent Liquidia from launching Yutrepia for PH-ILD.
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