MannKind and United Therapeutics NDA for Tyvaso DPI™ Accepted by U.S. FDA

MannKind Corporation and United Therapeutics Corporation announced that the U.S. FDA accepted for priority review the New Drug Application (NDA) for Tyvaso DPI™ (inhaled treprostinil) for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). 

The development marks the second compound formulated with MannKind's Technosphere® technology to be reviewed by the FDA, which is expected to be complete in October 2021. The FDA has also indicated that they have not identified any potential review issues at this time.

"We are energized by the acceptance of the Tyvaso DPI NDA for priority review," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "MannKind is driven to deliver therapeutics in ways that can help improve patient lives for the better. With this key regulatory step, we are excited to progress the next Technosphere product towards providing thousands of PAH and PH-ILD patients a more convenient method of treprostinil therapy administration."

MannKind is entering an expansion phase as it prepares to transition from producing clinical supply to building pre-launch inventory of Tyvaso DPI, pending FDA approval. The company's manufacturing and R&D facility in Danbury is scaling up by hiring more than 100 positions, as well as readying essential equipment and production lines. 

MannKind is hiring commercial manufacturing, engineering, quality control, warehouse operations and maintenance specialists for both non-exempt and exempt positions and plans to fill these before the end of 2021. 

MannKind and United Therapeutics are also developing BluHale®, a Bluetooth-connected accessory for the Tyvaso DPI inhaler with a companion mobile application intended to help patients track information about their inhaler use.