Liquidia Files Legal Challenge Against FDA Decision to Grant 3-Year New Clinical Investigation Exclusivity to Tyvaso DPI

07:09 AM EDT, 08/22/2024 (MT Newswires) -- Liquidia (LQDA) said Thursday it has filed a legal challenge to the US Food and Drug Administration's recent decision to grant a three-year new clinical investigation exclusivity to United Therapeutics' (UTHR) Tyvaso DPI.

The complaint was filed with the US District Court of the District of Columbia.

Liquidia said the granted exclusivity to Tyvaso resulted in the delay of the final approval of Yutrepia, or treprostinil, inhalation powder until May 23, 2025.

Yutrepia is intended to treat pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.

"The FDA's action improperly allows United Therapeutics to tack on yet another regulatory exclusivity, stifling competition and patient choice," Liquidia Chief Executive Roger Jeffs said in a statement.

Jeffs also said the FDA decision violates congressional intent, which limits new clinical investigation exclusivity to "true innovations that are supported by new clinical studies that demonstrate safety and/or efficacy of the innovation."

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