US FDA delays traditional approval for Liquidia Corp's inhaled drug

(Reuters) -The U.S. Food and Drug Administration on Monday delayed traditional approval for Liquidia Corp's drug for types of lung disorders, and allowed only tentative clearances, sending its shares plummeting nearly 37% before the bell.

The company said it has to wait for the expiration of regulatory exclusivity to United Therapeutics (NASDAQ:UTHR )' Tyvaso DPI on May 23, 2025 before its drug can receive a final approval for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Liquidia said it will challenge the regulatory exclusivity to United's Tyvaso DPI, which encompasses chronic use of essentially any dry-powder formulation of treprostinil in both PAH and PH-ILD, granted in May 2022.

The health regulator's decision marks another setback to Liquidia's efforts to market its drug, yutrepia, which is also a dry powder formulation of treprostinil.

The drug was granted tentative approval in 2021 to treat PAH, but the company could not market it due to a regulatory stay related to a patent infringement dispute with United Therapeutics for Tyvaso.

Both Tyvaso DPI and yutrepia are delivered through a palm-sized device, making them more convenient than bulky nebulizers.



The FDA granted tentative approval yet again to yutrepia for PAH on Monday, as well as for PH-ILD, after the health regulator said it was still reviewing Liquidia's marketing application in January.

PH-ILD is a group of disorders that cause scarring in the lungs.

Source: Investing.com