MannKind and United Snag Priority Review for Pulmonary Hypertension Drug

The U.S. Food and Drug Administration (FDA) has accepted for priority review MannKind’s and United Therapeutics’ New Drug Application (NDA) for Tyvaso DPI™, a treatment for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

In September 2018, both MannKind and United Therapeutics entered into a global and exclusive licensing and collaboration agreement to develop and commercialize Tyvaso DPI. The therapy is a next-generation formulation of treprostinil, incorporating dry powder formulation technology and Dreamboat® inhalation device technology previously used to develop MannKind’s FDA-approved Afrezza® (insulin human) Inhalation powder. Tyvaso DPI is the second FDA-reviewed therapeutic compound that has been formulated with MannKind’s Technosphere® technology. 

In a statement, MannKind and United Therapeutics said the priority review of the two companies’ NDA for Tyvaso DPI is expected to complete sometime in October 2021. At this time, according to the companies, the agency has not found any potential review issues to hold up ultimate approval.

“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,” said MannKind’s Chief Executive Officer, Michael Castagna, PharmD, in a statement.

Concurrently, United Therapeutics and MannKind are in the process of developing a Bluetooth-connected accessory for the Tyvaso DPI inhaler, dubbed BluHale®. The companies are also developing a companion mobile app to help patients monitor and track data and information about their inhaler use.

The FDA has communicated with United Therapeutics that the NDA approval will be contingent on an inspection of MannKind-operated manufacturing facility used to develop Tyvaso DPI. Both the FDA and MannKind have set an inspection completion date sometime in the third quarter of this year.

MannKind and United Therapeutics submitted the NDA for Tyvaso DPI along with data from the BREEZE clinical trial. This study showed the therapy was safe and tolerable in patients with PAH who transitioned from the Tyvaso® (treprostinil) Inhalation Solution. Another study conducted in healthy volunteers showed the comparable treprostinil exposure between Tyvaso Inhalation Solution and Tyvaso DPI.

Currently, MannKind noted it is entering an expansion phase to prepare a transition from generating a clinical supply of the therapy to building pre-launce inventory, as long as the FDA approval goes smoothly. To prepare, the manufacturing and R&D facility is in the process of bringing on over 100 new positions. Both non-exempt and exempt jobs currently open at MannKind can be found in the commercial manufacturing, engineering, quality control, warehouse operations, and maintenance areas.

“It’s exciting to bring growth and expansion to Danbury and the surrounding communities as MannKind continues to build upon its Technosphere® technology,” according to a statement made by Joe Kocinsky, MS, MBA, the Chief Technology Officer at MannKind. “Our site will practically double in size as we spend the next months preparing for Tyvaso DPI, pending FDA approval.”