United Therapeutics (UTHR) recently announced data from an open-label phase 1 study of Tyvaso DPI (inhaled treprostinil) in Pulmonary Arterial Hypertension or PAH. The study met its primary endpoint of demonstrating safety and tolerability in patients with PAH transitioning from Tyvaso (treprostinil) inhalation solution. Also, a pharmacokinetic (PK) study in healthy volunteers demonstrated comparable treprostinil exposure between Tyvaso DPI and Tyvaso Inhalation Solution.
Currently approved Tyvaso is a nebulized formulation while Tyvaso DPI is a dry powder formulation and, if approved, will provide a more convenient method of administration. The company plans to submit an NDA in April 2021 with an indication to treat pulmonary arterial hypertension (PAH), as well as pulmonary hypertension associated with interstitial lung disease (PH-ILD) based on the INCREASE study. It will also use a priority review voucher for the NDA, which will reduce the approval period by 4 months.
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