United Therapeutics’ Tyvaso DPI Receives the US FDA’s Approval for Treatment of PAH and PH-ILD
Shots:
- The approval was based on the (BREEZE) open-label study evaluating Tyvaso DPI in 51 patients with PAH. Additionally, commercialization activities are currently underway with patient availability is expected in June 2022
- The results from the patients with PAH who were transitioned from Tyvaso inhalation sol. to Tyvaso DPI demonstrated safety and tolerance @3wk. treatment period, improvements in six-minute walk distance, device preference and satisfaction & PROs
- Tyvaso DPI marks the first US FDA approved dry powder inhaler therapy & is indicated for use in PAH and PH-ILD and represents a new formulation and inhalation device for inhaled treprostinil
Ref: Businesswire | Image: United Therapeutics
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