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Liquidia (NASDAQ:LQDA) late on Aug. 27 filed a request for a preliminary injunction against the U.S. FDA in a District of Columbia federal court regarding the agency’s granting of 3-year exclusivity for United Therapeutics (NASDAQ:UTHR) Tyvaso DPI (treprostinil).
Liquidia has been attempting to win full approval for its own version of treprostinil, Yutrepia. It has tentative approval from the agency, but won’t likely get full approval until May 23, 2025, when Tyvaso DPI’s 3-year new clinical investigation (“NCI”) exclusivity ends.
The injunction request states that the decision to grant that exclusivity “exceeded FDA’s statutory authority, was arbitrary and capricious, and was contrary to law.”
“The Exclusivity Decision unlawfully penalizes the sponsor (Liquidia) who actually developed the innovation at issue (dry powder inhalation) long before United Therapeutics Corporation (“UTC”) filed the Tyvaso DPI NDA, while prolonging UTC’s decades-long monopoly on treprostinil for another nine months— far beyond the statutory limits prescribed by Congress — to the detriment of patients, competition, and the public health.”
In a memo supporting its request, Liquidia noted that when the FDA approved Tyvaso DPI, it also concluded that no “new clinical investigations” supported that approval, which would apparently make the drug ineligible for NCI exclusivity. “Yet, on August 16, 2024, FDA reversed course and awarded the precise exclusivity it found inapplicable at the time of approval in 2022.”
“FDA’s Exclusivity Decision is an affront to patients in need of safe and effective treatments, the drug development process itself, and the intent of Congress, and it cannot lawfully stand.”
