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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Covid vaccine makers Pfizer Inc. and BioNTech SE announced a new $3.2 billion vaccine supply deal with the U.S. Government, as the country is bracing for a Covid outbreak this fall. Under the deal, the U.S. government will receive 105 million doses (30 µg, 10 µg and 3 µg) of Pfizer -BioNTech covid vaccines initially. The order may include adult Omicron-adapted COVID-19 vaccines. Samsung Electronics Co. has started the initial mass production of 3-nanometer or nm chips, which is considered as the most advanced chip in the world. In its move, the South Korean tech major beats rival Taiwan Semiconductor Manufacturing Co., the world's largest chip manufacturer, which is reportedly in the process to build one. Bryant Ranch Prepack Inc. is recalling certain Morphine Sulfate Extended-Release Tablets citing incorrect labeling, the U.S. Food and Drug Administration said. The recall involves one lot of Morphine Sulfate 30 mg Extended-Release tablets, and one lot of Morphine Sulfate 60 mg Extended-Release tablets to the consumer level.
Follow RTT