Tyvaso DPI Earns FDA Priority Review Status

The U.S. Food and Drug Administration (FDA) has granted priority review status to the application seeking approval of Tyvaso DPI — a dry powder inhaled formulation of treprostinil — for the treatment of both pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Priority review shortens the FDA’s review period to eight months, down from the standard one year. United Therapeutics, developers of Tyvaso DPI and other treprostinil formulations including Tyvaso (inhaled), Orenitram (oral), and Remodulin (infusion/injection), submitted the new drug application (NDA) and a request for priority review in April.

“We are energized by the acceptance of the Tyvaso DPI NDA for priority review,” Michael Castagna, CEO of MannKind, said in a press release.

MannKind developed the hand-held Dreamboat inhalation device used with Tyvaso DPI. MannKind and United are collaborating in developing and commercializing Tyvaso DPI, after having entered into an exclusive global licensing and collaboration agreement in 2018.

Tyvaso, used to treat patients with PAH or PH-ILD, lowers blood pressure by relaxing blood vessels. This makes them wider, allowing blood to travel through them more easily. Tyvaso DPI is intended to provide a more convenient formulation relative to Tyvaso.

The NDA contained data from the recently completed Phase 1 BREEZE study (NCT03950739) about the safety and tolerability of Tyvaso DPI.

Participants in this study had PAH and were transitioning to the new formulation from a stable Tyvaso regimen. Over the course of the trial, they showed improvements in their ability to perform exercise, reported fewer PAH symptoms with a lower overall impact, and generally greater satisfaction using Tyvaso DPI.

Trial data also showed that the amount of Tyvaso DPI available for use in a patient’s body varied less from one person to another compared to Tyvaso, suggesting the new formulation provided more precise dosing.

In anticipation of transitioning from manufacturing a small clinical supply of Tyvaso DPI to a larger pre-launch inventory, MannKind is scaling up its research and development facility in Danbury, Connecticut. The company is hiring more than 100 workers in a variety of areas, as well as readying essential equipment and production lines.

“It’s exciting to bring growth and expansion to Danbury and the surrounding communities as MannKind continues to build upon its Technosphere technology,” said Joe Kocinsky, MannKind’s chief technology officer. “Our site will practically double in size as we spend the next months preparing for Tyvaso DPI, pending FDA approval.”