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

WESTLAKE VILLAGE, Calif. and DANBURY, Conn., April 19, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) and United Therapeutics (Nasdaq: UTHR) reached a milestone today in the development of Tyvaso DPI^a?? as United Therapeutics submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA).
a??The NDA submitted today by United Therapeutics builds upon a drug master file previously submitted by MannKind,a?? said Michael Castagna, CEO of MannKind Corporation. a??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.a??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^A®A inhalation device technology used in MannKinda??s Afrezza^A®A (insulin human) Inhalation Powder, which was approved by the FDA in 2014.Tyvaso DPI, if approved, is expected to provide a convenient choice of inhaled administration for patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). There are approximately 45,000 treated PAH patients in the U.S. and United Therapeutics estimates at least 30,000 treatable PH-ILD patients in the U.S.United Therapeutics has applied a priority review voucher to the NDA that could provide for an FDA decision by December 2021. The FDA must first accept the application for review and issue a formal decision date in accordance with the Prescription Drug User Fee Act.