FDA approves United Therapeutics' Tyvaso DPI for PAH and PH-ILD; launch underway

UNITED THERAPEUTICS Corp

FDA approved Tyvaso DPI (treprostinil inhalation powder) for PAH (WHO Group 1) and PH-ILD (WHO Group 3).
First dry powder inhaler approved for PAH and PH-ILD; patient availability expected June 2022.
BREEZE study (51 PAH patients) demonstrated safety/tolerance and improved 6-minute walk distance.
TYVASO DPI and Tyvaso Inhalation Solution are only FDA-approved therapies for PH-ILD.
Commercial launch activities underway, offering convenient treprostinil delivery via hand-held inhaler.

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