FDA grants tentative approval of Yutrepia

The US Food and Drug Administration (FDA) has granted tentative approval of Liquidia Corp’s (Nasdaq: LQDA) Yutrepia (treprostinil) inhalation powder to treat adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Tentative approval indicates that Yutrepia has met all regulatory standards for quality, safety and efficacy required for approval in the USA, but must await the expiration of regulatory exclusivity of a competing product before final approval can be granted.

This mean that Liquidia must wait until its competitor’s exclusivity clock runs out on May 23, 2025 to score final approval.