Liquidia sues FDA over exclusivity rights granted to United’s Tyvaso
Liquidia challenging FDA's decision that delays final approval of Yutrepia
Liquidia is suing the U.S. Food and Drug Administration (FDA) to challenge a decision that delays the final approval of Yutrepia, its inhaled dry-powder formulation of treprostinil, arguing that the delay unfairly limits patient access to important treatment.
Yutrepia was granted tentative approval in 2021 to improve the ability to exercise in adults with pulmonary arterial hypertension (PAH), an indication extended earlier this month to pulmonary hypertension associated with interstitial lung disease (PH-ILD).
The lawsuit was filed in the U.S. District Court for the District of Columbia over the FDA’s decision to grant United Therapeutics a three-year exclusivity period to Tyvaso DPI, which prevents other companies from competing for market share until mid-2025.
Yutrepia’s final OK not considered until end of Tyvaso’s exclusivity period
While Yutrepia meets all required standards for quality, safety, and efficacy in the U.S., final approval cannot be considered until the end of the exclusivity period for Tyvaso DPI, which remains the only dry-powder inhaled formulation of treprostinil approved by the FDA to improve the ability to exercise in adults with PAH or PH-ILD.
“The FDA’s action improperly allows United Therapeutics to tack on yet another regulatory exclusivity, stifling competition and patient choice,” Roger Jeffs, PhD, Liquidia’s CEO, said in a company press release.
New clinical investigation (NCI) exclusivity offers incentives to further the development of previously approved medications. It usually protects new indications or dosing regimens that differ from those of the initial approval, and is limited to innovations based on new clinical studies.
Liquidia argues that Tyvaso DPI doesn’t meet these criteria and shouldn’t have received NCI exclusivity.
“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,” Jeffs said.
“This decision violates clear congressional intent to allow NCI exclusivity only for true innovations that are supported by new clinical studies that demonstrate safety and/or efficacy of the innovation,” he added.
Yutrepia contains treprostinil, a compound that widens and relaxes blood vessels, thereby reducing blood pressure. This is expected to ease symptoms caused by pulmonary hypertension, or high blood pressure in the blood vessels that supply the lungs.
The FDA’s tentative approval of Yutrepia was based on INSPIRE (NCT03399604), a Phase 3 study showing the therapy could safely improve exercise capacity and quality of life in adults with PAH, including in those new to inhaled treprostinil or in those switching from Tyvaso (nebulized treprostinil).
United previously filed a complaint against the FDA for accepting Liquidia’s amended new drug application seeking to extend Yutrepia’s tentative approval to PH-ILD, which causes the lungs to become damaged and scarred. However, earlier this month, the company withdrew the complaint.
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