The Food and Drug Administration (FDA) has granted tentative approval for Yutrepia (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension (PAH) to improve exercise ability in adults with New York Heart Association (NYHA) Functional Class II-III symptoms.

Yutrepia is an inhaled dry powder formulation of treprostinil delivered through a palm-sized device. It utilizes Liquidia’s proprietary technology to deliver drug particles for optimal deposition in the lung. 

According to the FDA, Yutrepia met the required regulatory standards for quality, safety and efficacy for approval. However, full approval of Yutrepia is not expected until the expiration of the regulatory stay pursuant to the Drug Price Competition and Patent Term Restoration Act on October 27, 2022. The Company may be able to market the product earlier depending upon resolution of ongoing litigation with United Therapeutics, the makers of Tyvaso.

Tyvaso is currently approved for PAH (WHO Group 1) and pulmonary hypertension associated with interstitial lung disease (WHO Group 3). The inhalation solution is administered via the Tyvaso Inhalation System. A New Drug Application for Tyvaso DPI, a drug-device combination therapy that consists of a dry powder formulation of treprostinil and a small, portable, dry powder inhaler, is currently under FDA review.


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“The tentative approval for Yutrepia is another step toward providing an important option for patients with PAH in the US,” said Dr Tushar Shah, Chief Medical Officer of Liquidia. “We believe Yutrepia can improve the limitations of current nebulized therapies by allowing the administration of an expanded dose range of inhaled treprostinil using a proven, convenient, palm-sized device.” 

Reference

FDA grants tentative approval for Liquidia’s Yutrepia™ (treprostinil) inhalation powder. News release. Liquidia Corporation. November 8, 2021. Accessed November 11, 2021. https://www.liquidia.com/news-releases/news-release-details/fda-grants-tentative-approval-liquidias-yutrepiatm-treprostinil.