Morrisville-based Liquidia has filed a lawsuit against the U.S. Food and Drug Administration to challenge its decision to grant exclusivity to a competing drug for lung disease.
The FDA granted Liquidia tentative approval for its drug Yutrepia, an inhalation powder that treats two types of lung disease. However, the FDA ruled it would not give Liquidia final approval until a three-year exclusivity agreement expired on May 23, 2025, for a similar drug, Tyvaso DPI, made by Silver Spring, Maryland-based United Therapeutics.
Liquidia’s stock price has slumped more than 31% in the last four days. It was trading for about $9.50, after closing at $14.20 on Friday. Liquidia has a 52-week range of between $5.71-$16.99.
“The FDA’s action improperly allows United Therapeutics to tack on yet another regulatory exclusivity, stifling competition and patient choice,” says Liquidia CEO Roger Jeffs in a release. “This decision violates clear congressional intent to allow NCI (new clinical investigation) exclusivity only for true innovations that are supported by new clinical studies that demonstrate safety and/or efficacy of the innovation. It is our strong belief that the FDA’s decision to grant Tyvaso DPI this new NCI exclusivity should be vacated, and Liquidia should be allowed to bring Yutrepia to market for the benefit of patients immediately.”
Yutrepia treats pulmonary arterial hypertension, a rare, chronic, progressive disease caused by hardening and narrowing of the pulmonary arteries that can lead to right heart failure and eventually death. Currently, an estimated 45,000 patients are diagnosed and treated in the United States. There is currently no cure for PAH, so the goals of existing treatments are to alleviate symptoms, maintain or improve functional class, delay disease progression, and improve quality of life, according to Liquidia.
Tyvaso DPI gained approval on May 23, 2022.