Benzinga | Apr 19, 2021 06:01AM EDT

Mannkind and United Therapeutics Reach a Milestone in the Development of Tyvaso DPI With New Drug Application Submitted to the FDA

MannKind Corporation (NASDAQ:MNKD) and United Therapeutics (NASDAQ:UTHR) reached a milestone today in the development of Tyvaso DPI(tm) as United Therapeutics submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA).



"The NDA submitted today by United Therapeutics builds upon a drug master file previously submitted by MannKind," said Michael Castagna, CEO of MannKind Corporation. "We are excited to see the second compound formulated with our technology complete a rigorous clinical development program. If approved by the FDA, Tyvaso DPI is expected to provide a major advancement in the delivery of inhaled treprostinil for PAH and PH-ILD patients."

MannKind and United Therapeutics entered into a worldwide exclusive licensing and collaboration agreement in September 2018 for the development and commercialization of Tyvaso DPI, a dry powder formulation of treprostinil, delivered via a small, portable dry powder inhaler. Tyvaso DPI incorporates the dry powder formulation technology and Dreamboat(r) inhalation device technology used in MannKind's Afrezza(r) (insulin human) Inhalation Powder, which was approved by the FDA in 2014.