The U.S. Food and Drug Administration (FDA) is poised to soon issue a final determination on Yutrepia, an inhaled dry powder formulation of treprostinil, up for approval to treat both pulmonary hypertension associated with interstitial lung disease (PH-ILD) and pulmonary arterial hypertension (PAH).
The FDA granted Yutrepia tentative approval for PH-ILD last year and for PAH in 2021. These tentative approvals meant that the FDA judged that Yutrepia met all criteria for quality, safety, and efficacy, but the therapy was not able to be brought to market.