Liquidia (LQDA) has announced that the FDA has granted tentative approval for YUTREPIA, an inhalation powder intended to treat adults with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. This tentative approval signifies that YUTREPIA has satisfied all regulatory requirements but must wait until the expiration of the regulatory exclusivity of a competing product for final approval. The final approval for YUTREPIA for PAH and PH-ILD is anticipated after the 3-year regulatory exclusivity for Tyvaso DPI expires on May 23, 2025.
CEO Roger Jeffs expressed disappointment and disagreement with the FDA’s decision to simultaneously grant regulatory exclusivity to United Therapeutics for Tyvaso DPI. This exclusivity encompasses any chronic use of dry-powder formulations of treprostinil within the approved indications for a 3-year period, following the new dosage form approval on May 23, 2022. Jeffs stated, "We plan to take swift action to challenge the FDA's broad grant of regulatory exclusivity and ensure that patients gain access to YUTREPIA with minimal delay."
As a result of this news, Liquidia's stock saw a 22% decline in pre-market trading on Monday.
