According to Liquidia Corporation, the FDA has informed the company that the agency will not meet the PDUFA goal date of January 24, 2004 for completion of the review of Liquidia’s sNDA to add an indication for pulmonary hypertension associated with interstitial lung disease (PH-ILD) for Yutrepia treprostinil DPI. The company said that the FDA “informed the Company that it is confirming the process for adding the PH-ILD indication as an amendment to the NDA for Yutrepia” and has not yet set a new PDUFA goal date.
Yutrepia was tentatively approved by the FDA for the treatment of pulmonary arterial hypertension In November 2021. United Therapeutics, whose legal efforts alleging patent infringement by Yutrepia are ongoing, filed an additional patent infringement suit in response to Liquidia’s submission of the sNDA.
Liquidia CEO Roger Jeffs commented, “We are in active communication with the FDA regarding the process we followed to amend our NDA to add PH-ILD to the labeled indication. Whether the NDA is amended or supplemented, we will continue to prepare for the final FDA approval of Yutrepia to treat both PAH and PH-ILD patients following the expiration of regulatory exclusivity for Tyvaso on March 31, 2024. As communicated by the tentative approval to treat PAH, Yutrepia has already met the regulatory standards for quality, safety and efficacy. We remain committed to addressing the unmet needs across all patients whose lives may be improved by the unique benefits of Yutrepia.”
Read the Liquidia press release.
