Yutrepia Approved for PAH & PH-ILD – FDA Update
- Liquidia Corporation has announced that the Food and Drug Administration (FDA) has granted final approval for Yutrepia inhalation powder.
- Roger Jeffs, Liquidia CEO, hailed the approval as a victory for patients and physicians, emphasizing Yutrepia's potential as a "best-in-class" treprostinil option.
- Yutrepia stands out as the first dry-powder prostacyclin treprostinil formulation, utilizing Liquidia's PRINT technology.
The FDA has approved Yutrepia, a dry-powder formulation of treprostinil, for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). liquidia Corporation’s innovative drug marks a notable advancement in treatment options, offering patients a portable and easily titratable alternative.This approval, supported by positive results from the INSPIRE study, signifies a major win for those battling PAH and PH-ILD. Yutrepia, utilizing liquidia’s PRINT technology, is poised to possibly become a leading treatment. News Directory 3 reports on the latest developments, including the pending litigation from United therapeutics. Explore the implications of this landmark decision and learn about Liquidia’s upcoming webcast. Discover what’s next.
Liquidia’s Yutrepia Receives FDA Approval for PAH and PH-ILD
Liquidia Corporation has announced that the Food and Drug Administration (FDA) has granted final approval for Yutrepia inhalation powder. This pulmonary hypertension treatment is indicated for both pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
Roger Jeffs, Liquidia CEO, hailed the approval as a victory for patients and physicians, emphasizing Yutrepia’s potential as a “best-in-class” treprostinil option. He cited its portability, tolerability, and ease of titration as key benefits. The company is preparing to launch Yutrepia and highlight its unique advantages to healthcare providers and patients.
FDA approval illustration” width=”476″ height=”267″>Yutrepia stands out as the first dry-powder prostacyclin treprostinil formulation, utilizing Liquidia’s PRINT technology. This technology allows for customization of particle design, according to Rajeev Saggar, MD, Liquidia’s chief medical officer.
The FDA’s decision was supported by data from the phase 3 INSPIRE study, which involved 121 PAH patients. The study indicated that Yutrepia was safe and well-tolerated,regardless of prior treprostinil exposure.Common side effects observed included cough, headache, throat irritation, and dizziness.
While yutrepia received tentative approval last year, full approval was contingent on the expiration of regulatory exclusivity for a competing product.
United Therapeutics previously filed a patent infringement complaint against Liquidia and has sought a temporary restraining order and preliminary injunction to prevent the launch of Yutrepia. A decision on the motion is pending following oral arguments in U.S. District Court on May 20,2025.
“Today, we celebrate for the patients and physicians who will now have access to a potential best-in-class dry-powder form of treprostinil with exceptional portability, tolerability, titratability and durability,”
Roger Jeffs, Liquidia CEO
What’s next
Liquidia will host a webcast on Tuesday, May 27, at 8:30 a.m. to discuss the commercial launch plans for Yutrepia, offering further insights into its availability and use for pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.