In addition to ongoing litigation against Liquidia Corporation alleging infringement of patents covering Tyvaso inhaled treprostinil by Liquidia’s Yutrepia treprostinil DPI, United Therapeutics Corporation announced that it is now suing the FDA over its handling of Liquidia’s sNDA to add PH-ILD as an indication for Yutrepia.
United Therapeutics calls the sNDA “unlawful” and alleges that the agency “inappropriately denied United Therapeutics its right to obtain a stay of Liquidia’s final approval until United Therapeutics’ pending patent infringement claim against Liquidia can be resolved.” The company says that Liquidia should be required to file a new NDA for the second indication instead of an sNDA, a procedure it says “is critical to ensure the proper review and approval of new drug applications in a fair, equitable manner consistent with the FDA’s prior practices with which industry has complied for decades.”
The FDA tentatively approved Yutrepia for the treatment of pulmonary arterial hypertension In November 2021. The agency accepted the sNDA to add the PH-ILD indication in September 2023 and set a PDUFA goal date of January 24, 2024; however, at the goal date, the FDA informed Liquidia that it had not completed the review of the application and was instead evaluating the process for adding the additional indication.
In August 2020, United Therapeutics submitted an sNDA to the FDA seeking approval of Tyvaso inhalation solution for the treatment of PH-ILD, and the agency granted approval of the sNDA for that indication in March 2021. Tyvaso inhalation solution had initially been approved by the FDA for the treatment of pulmonary arterial hypertension (PAH) in 2009. Tyvaso DPI was approved for both PAH and PH-ILD in May 2022.
United Therapeutics Executive VP of Global Regulatory Affairs commented, “The FDA is a global leader among public health agencies, but sometimes legal and regulatory precedents are missed. We are simply asking that the FDA apply its own rules and precedents consistently to honor the Hatch-Waxman balance struck by Congress between innovators and imitators: Liquidia can rely on United Therapeutics’ innovation to speed its path to market, but the cost of that shortcut is that Liquidia must address the infringement claim against it before rushing to market.”
Read the United Therapeutics press release.
