You are here

NDA Submitted for Treprostinil, Potential Treatment of Pulmonary Arterial Hypertension

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 incremental benefit of an add-on therapy in PAH patients who are already receiving an approved background therapy. The study population consisted of 235 patients who were optimized on an approved oral therapy for PAH, either bosentan (Tracleer(R)), an endothelin receptor antagonist, or sildenafil (Revatio(R)), a phosphodiesterase-5 inhibitor. The majority of patients were New York Heart Association (NYHA) Class III (~98%) of varied etiologies, including idiopathic or familial PAH (~60%), collagen vascular disease associated PAH (~30%), and PAH associated with HIV, anorexigens or other associated conditions (~10%).

The primary efficacy endpoint of the TRIUMPH-1 clinical trial was the change in six-minute walk (6MW) distance at 12 weeks measured at peak exposure, defined by the trial protocol as 10-60 minutes after administration of ITRE relative to baseline. Analysis of the TRIUMPH-1 clinical trial results confirmed an improvement in median 6MW distance of approximately 20 meters (p

Source: United Therapeutics Corporation

Recent Headlines

Two-Thirds of U.S. Alzheimer’s Cases Are Women, And It’s Not Just Because They Live Longer
Recarbrio Should be Reserved For Limited/No Alternative Antibacterial Treatment Cases
Breast Cancer, Gastrointestinal Tumors Most Common Types
NY Hospitals Required to Implement Protocols in Suspected Cases
Presence of BOK Protein Key for Positive Treatment Response
Patient Access to Inhaler Use Data Could Improve Asthma Management
Overall Survival 4.3 Months’ vs. 1.5 Months for Traditional Regimens