Yutrepia FDA Approval Status
Last updated by Judith Stewart, BPharm on Sep 26, 2023.
FDA Approved: No (Tentative Approval)
Brand name: Yutrepia
Generic name: treprostinil
Dosage form: Inhalation Powder
Previous Name: LIQ861
Company: Liquidia Technologies, Inc.
Treatment for: Pulmonary Arterial Hypertension (PAH); Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD)
Yutrepia (treprostinil) is an inhaled dry powder formulation of treprostinil for the treatment of pulmonary arterial hypertension (PAH) to improve exercise ability in adult patients with New York Heart Association (NYHA) Functional Class II-III symptoms.
- On November 8, 2021, the U.S. Food and Drug Administration (FDA) granted tentative approval for Yutrepia (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension (PAH) to improve exercise ability in adult patients with NYHA Functional Class II-III symptoms. Tentative approval indicates that Yutrepia has met all regulatory standards for quality, safety and efficacy required for approval in the United States.
- Due to a regulatory stay pursuant to the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act), Yutrepia cannot yet be marketed in the United States. In June 2020, United Therapeutics filed a lawsuit against Liquidia for alleged infringement of three patents related to Tyvaso®. As a result, the FDA cannot give final approval of Yutrepia until the expiration of the regulatory stay on October 27, 2022, or earlier resolution or settlement of the ongoing litigation.
- On September 25, 2023, it was announced that the FDA had accepted for review the amendment to the tentatively approved new drug application (NDA) for Yutrepia. The company is seeking to add the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) to the label.
- The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of January 24, 2024.
Development timeline for Yutrepia
Further information
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