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 DPIa?? 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 DreamboatA inhalation device technology used in MannKinda??s AfrezzaA (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.
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