MannKind and United Therapeutics Reports the US FDA’s Acceptance of NDA for Priority Review of Tyvaso DPI to Treat PAH and PH-ILD

June 17, 2021 Auto Bot Acceptance, FDA, NDA, Priority Review, regulatory, United Therapeutics 0

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 to­ read full press release/ article | Ref: PR Newswire | Image: United Therapeutics

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