Key takeaways:
- Liquidia Company obtained remaining FDA approval for Yutrepia for the therapy of PAH and PH-ILD.
- The corporate obtained tentative approval final yr.
The FDA accepted Yutrepia inhalation powder for the therapy of pulmonary arterial hypertension and pulmonary hypertension related to interstitial lung illness, Liquidia Company introduced in a press launch.
“At the moment, we have a good time for the sufferers and physicians who will now have entry to a possible best-in-class dry-powder type of treprostinil with distinctive portability, tolerability, titratability and sturdiness,” Liquidia CEO Roger Jeffs mentioned within the launch. “With immediately’s milestone, our industrial crew is ready to launch YUTREPIA and convey significant change to the lives of sufferers in want, and we look ahead to talking with physicians and sufferers in regards to the distinctive advantages of YUTREPIA within the days and weeks forward.”
Liquidia Company obtained remaining FDA approval for Yutrepia for the therapy of PAH and PH-ILD. Picture: Adobe Inventory.
Based on the Liquidia, Yutrepia is the primary and solely prostacyclin dry-power formulation of treprostinil. It’s formulated by means of proprietary particle replication in non-wetting templates (PRINT) expertise, which permits the corporate to customise the design of the particles, Liquidia Chief Medical Officer Rajeev Saggar, MD, informed Healio final yr.
The approval was primarily based, partially, on the outcomes of the section 3 INSPIRE examine, which included 121 sufferers with PAH. Yutrepia seemed to be protected and well-tolerated amongst sufferers whether or not or not that they had been uncovered to trepostinil earlier than, the discharge said.
The most typical hostile occasions related to Yutrepia embrace cough, headache, throat irritation and dizziness.
Yutrepia was tentatively accepted by the FDA final yr, however the FDA was ready for regulatory exclusivity of a competing product to run out earlier than granting full approval.
As Healio beforehand reported, United Therapeutics filed a grievance of patent infringement in opposition to Liquidia. United Therapeutics obtained FDA approval for its dry powder inhaler (Tyvaso) to deal with PAH and PH-ILD in Could 2022.
Based on the press launch from Liquidia, United Therapeutics filed a movement for a short lived restraining order and preliminary injunction to cease Liquidia from launching Yutrepia. The businesses participated in oral arguments within the U.S. District Court docket on Could 20, 2025, and the movement is pending with the court docket.
Liquidia is internet hosting a webcast at 8:30 a.m. on Tuesday, Could 27, to debate the industrial launch of Yutrepia.
