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United Therapeutics Files New Drug Application For Tyvaso DPI- Quick Fats

MannKind Corporation (MNKD) and United Therapeutics (UTHR) today said United Therapeutics has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for its Tyvaso DPI.

Tyvaso DPI is a dry powder formulation of Tyvaso, delivered via a portable inhaler, for the treatments of pulmonary arterial hypertension (PAH), and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Tyvaso (treprostinil) inhalation solution, developed by United Therapeutics was approved in 2009 for the treatment of Pulmonary Arterial Hypertension.

Tyvaso DPI incorporates the same dry powder formulation technology and Dreamboat inhalation device technology used in MannKind's Afrezza Inhalation Powder, which was approved in 2014.

United Therapeutics has applied a priority review voucher to its NDA for Tyvaso DPI. A decision is expected by December 2021.

In 2018, MannKind and United Therapeutics had entered into a worldwide licensing and collaboration agreement for the development and commercialization of Tyvaso DPI.

"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," said Michael Castagna, CEO of MannKind Corporation.

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