Liquidia Corporation announced on August 20, 2024, that the US Food and Drug Administration (FDA) has granted tentative approval for YUTREPIA™ (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The approval is supported by the Phase 3 INSPIRE trial, which demonstrated YUTREPIA’s safety and tolerability.
YUTREPIA meets all regulatory standards for quality, safety, and efficacy, but the final approval is pending the expiration of a 3-year regulatory exclusivity for United Therapeutic’s Tyvaso DPI on May 23, 2025. Liquidia plans to challenge this exclusivity to expedite YUTREPIA’s availability.
Read more on Liquidia’s press release at this link