Shots:

• The NDA is based on data from the BREEZE study evaluating Tyvaso DPI in 51 patients with PAH transitioning from Tyvaso inhalation solution which demonstrates the safety & tolerability of Tyvaso DPI
• Additionally- a separate PK study in 36 healthy volunteers demonstrates comparable treprostinil exposure b/w Tyvaso DPI & Tyvaso Inhalation Solution while FDA indicates that they have not identified any potential review issues at this time
• Tyvaso DPI marks the 2nd compound formulated with MannKind’s Technosphere technology to be reviewed by FDA- is expected to complete in Oct’2021. Both companies have jointly targeted to complete the survey in Q3’21

Source 1- Source 2  | Ref: PR Newswire | Image: United Therapeutics