Liquidia's Yutrepia NDA slowed by addition of PH-ILD indication

The US Food and Drug Administration (FDA) has provided an update on its review of the New Drug Application (NDA) for Yutrepia (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

The FDA has informed USA-based Liquidia Corporation (Nasdaq: LQDA), the developer of the drug, that it is confirming the process for adding the PH-ILD indication as an amendment to the NDA for Yutrepia.

"We will continue to prepare for the final FDA approval of Yutrepia to treat both PAH and PH-ILD patients following the expiration of regulatory exclusivity for Tyvaso on March 31, 2024"