FDA Grants Tentative Approval for YUTREPIA, a New Treatment for Pulmonary Arterial Hypertension and Pulmonary Hypertension Associated with Interstitial Lung Disease

FDA Tentative Approval:
The U.S. FDA has granted tentative approval for YUTREPIA (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Regulatory Exclusivity:
The final approval of YUTREPIA is contingent upon the expiration of the 3-year regulatory exclusivity period for United Therapeutics' Tyvaso DPI, which ends on May 23, 2025.

Clinical Trials:
The tentative approval is based on the results of the Phase 3 INSPIRE trial, which demonstrated the safety and efficacy of YUTREPIA in both treprostinil-naïve patients and those transitioning from other inhaled treprostinil treatments.

Legal Dispute:
United Therapeutics has sued the FDA over the handling of Liquidia's NDA for YUTREPIA, claiming that the agency did not follow established rules and procedures.

Market Impact:
Despite meeting all regulatory standards, YUTREPIA cannot enter the U.S. market until after the regulatory exclusivity period for Tyvaso DPI expires, leading to a significant drop in Liquidia's shares.