New Drug Application for Inhaled Treprostinil Submitted to the U.S. Food and Drug Admi...( SILVER SPRING Md. June 30 /- Unit...),Health

SILVER SPRING, Md., June 30 /PRNewswire-FirstCall/ -- United Therapeutics Corporation (Nasdaq: UTHR) and its wholly-owned subsidiary, Lung Rx, Inc., announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of an inhaled formulation of treprostinil (ITRE) for the treatment of pulmonary arterial hypertension (PAH), a chronic, life-threatening disease. The submission starts a 60-day period during which the FDA will examine the application for completeness. If the FDA accepts the ITRE NDA for review, then it is expected to be subject to the standard 10- to 12-month review period before an action letter is issued.

"We believe that an inhaled formulation of treprostinil will be a very desirable option for PAH patients," said Martine Rothblatt, Ph.D., United Therapeutics' Chairman and Chief Executive Officer. "The completion of the NDA filing is a huge milestone in United Therapeutics' quest to develop as many formulations of treprostinil as possible to create better, more convenient therapies to treat the debilitating effects of PAH along the full spectrum of the disease."

The ITRE NDA is principally supported by data from the TRIUMPH-1 Phase III clinical trial.

About TRIUMPH-1

TRIUMPH-1 (TReprostinil Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension), was a randomized, double-blind, placebo- controlled trial of patients with PAH. ITRE is prepared once per day and administered in four daily inhalation sessions using the NEBU-TEC Optineb(TM) ultrasonic nebulizer, with each inhalation session taking approximately 1-2 minutes.

The TRIUMPH-1 clinical trial is one of the first pivotal trials to assess the increment
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