According to United Therapeutics and MannKind Corporation, the FDA has accepted United Therapeutics’ NDA for Tyvaso treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). United Therapeutics submitted the NDA in April 2021, and the agency is expected to complete the priority review in October 2021. In January 2020, United Therapeutics said that a clinical study called BREEZE had demonstrated that PAH patients could safely switch from Tyvaso treprostinil inhalation solution to the Tyvaso DPI.
MannKind, which licensed its Treprostinil Technosphere to United Therapeutics in September 2018, said that it expects the FDA to conduct an inspection of its Tyvaso DPI manufacturing facility in the third quarter of 2021. Like MannKind’s Afrezza insulin DPI, the Tyvaso DPI makes use of both the company’s Technosphere particle engineering technology and its Dreamboat delivery device.
In its own announcement, MannKind said that the company plans to hire an additional 100 employees at its Danbury, Connecticut facility to support commercial manufacturing of the DPI. MannKind Chief Technology Officer Joe Kocinsky said, “It’s exciting to bring growth and expansion to Danbury and the surrounding communities as MannKind continues to build upon its Technosphere technology. Our site will practically double in size as we spend the next months preparing for Tyvaso DPI, pending FDA approval.”
United Therapeutics CEO Martine Rothblatt commented, “The acceptance of the Tyvaso DPI NDA for review represents an important regulatory step toward offering this meaningful new product to both PAH and PH-ILD patients. If approved, Tyvaso DPI will represent yet another path to help us achieve our goal of serving 25,000 patients by the end of 2025.”
MannKind CEO Michael Castagna said, “We are energized by the acceptance of the Tyvaso DPI NDA for priority review. 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.”
Read the MannKind Corporation press release.
Read the United Therapeutics press release.
